🔍 RecallPedia

MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system

Class I - Dangerous
🏥 Medical Devices Recalled: June 10, 2025 SEDECAL SA Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI/DI 08436046002357, Serial Numbers: SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080, SN13000082, SN13000062, SN13000059, SN13000063, SN13000061, 13000067, 13000076, SN13000089, SN13000103, 13000085, SN13000146, 13000094, 13000092, 13000093, SN13000087, SN13000096, SN13000095, SN13000098, SN13000097, SN13000159, SN13000148, 13000145, 13000117, 14000051, SN13000149, 13000168, 14000015, 14000017, 14000014, 14000013, 14000019, 14000016, 13000167, 13000169, 14000011, 12000166, SN13000170, 13000200, 14000083, 14000008, 14000009, 13000201, SN13000179, SN13000181, 14000052, 14000026, 61918783, 14000049, 11000010, 13000068, 14000047, 14000041, 62072683, 62150154, 14000020, 62415613, SN14000097, SN14000096, 62587177, 14000116, 14000109, 14000119, 14000118, 14000126, 63604709, SN14000128, 64123668, 64216085, 14100105, 14100104, SN15100010, SN15100013, 15100104, 64904292, 15100100, 15100042, 15100040, 15100041, 15100226, 15100095, 65073897, 15100198, 15100116, 15100115, 15100127, 15100131, 15100135, 15100138, 15100144, 15100133, 14100034, SN14000127, 15100191, 66690596, 66936848, 15100274, 15100280, 15100276, SN16100008, 16100011, 67905914, 16100037, 16100038, 68025890, 68052381, 68054442, 68199970, 68233849, 68268597, 12000085, 68530038, 16200084, 16200028, 16200029, 16200049, 16200050, 16200051, 69022933, 16200064, 16200099, 70240554, 70378102, 70544668, 70545417, 70705340, 71001729, 72299716, 72555189, 21410094, 21410261, 21410347, 21410348, 22410146, 97579477, 97808946, 22410333, 17200007, 17200002, SN16200130, 16200129, 70929667, 16200137, 16200136, SN17200073, SN17200056, SN17200131, SN17200140, SN17200162, SN17200161, SN17200174, SN17200173, SN17200175, SN17200168, SN17200167, 16200049, SN17200217, 17200167, 17200168, SN18200010, SN18200011, SN18200049, SN18200088, SN18200112, SN18200133, SN18200124, 74854394, 75716470, SN18200176, SN18200186, SN18200209, SN18200341, 18200206, 18200205, SN19300073, SN19300085, SN19300098, 16, SN19300035, SN19300088, SN19300091, SN19300099, SN19300109, 23410012, SN21410184, SN19410126, 27, SN19410129, 23410046, 19410044, 19410046, 21410266, 21410280, 21410288, 21410290, 21410291, 21410293, 21410294, 21410320, 21410329, 21410330, 21410331, 21410332, 21410333, 21410334, 21410339, 21410340, 21410341, 21410342, 21410345, 21410349, 21410351, 21410360, 21410361, 21410362, 21410363, 21410365, 21410366, 21410367, 21410368, 21410369, 21410378, 21410379, 21410383, 21410384, 21410394, 21410402, 21410409, 21410410, 21410413, 21410414, 21410436, 22410002, 22410003, 22410021, 22410022, 22410023, 22410032, 22410033, 22410034, 22410035, 22410036, 22410050, 22410093, 22410121, 22410122, 22410132, 22410133, 22410142, 22410143, 22410145, 22410152, 22410153, 22410154, 22410155, 22410158, 22410159, 22410160, 22410161, 22410163, 22410164, 22410165, 22410189, 22410194, 22410195, 22410196, 22410197, 22410198, 22410199, 22410200, 22410201, 22410202, 22410203, 22410204, 22410218, 22410219, 22410226, 22410229, 22410236, 22410237, 22410238, 22410239, 22410245, 22410246, 22410247, 22410248, 22410251, 22410253, 22410315, 22410317, 22410318, 22410319, 22410320, 22410321, 22410322, 22410328, 22410331, 22410332, 23410008, 23410009, 23410010, 23410027, 23410040, 23410043, 23410044, 23410045, 23410047, 23410071, 23410072, 23410073, 23410078, 23410079, 23410080, 23410081, 23410086, 23410087, 23410088, 23410089, 23410090, 23410091, 23410092, 23410099, 23410102, 23410108, 23410120, 23410121, 23410122, 23410124, 23410125, 23410128, 23410133, 23410134, 23410135, 23410138, 23410139, 23410152, 23410164, 23410167, 23410171, 23410172, 23410174, 23410175, 23410176, 23410177, 23410193, 23410247, 23410257, 23410269, 23410270, 24410107, 24410146, 24410148, 24410149, 24410151, 24410168, 214410346, 214411180, 214411229, 23410118, SN0410157, SN1410049, SN19410034, SN19410035, SN19410037, SN19410071, SN19410092, SN19410093, SN19410094, SN19410097, SN19410098, SN19410099, SN19410100, SN19410101, SN19410102, SN19410115, SN19410116, SN19410123, SN19410127, SN19410135, SN19410136, SN19410137, SN20410029, SN20410030, SN20410032, SN20410033, SN20410034, SN20410044, SN20410045, SN20410049, SN20410060, SN20410063, SN20410064, SN20410065, SN20410066, SN20410071, SN20410072, SN20410073, SN20410074, SN20410081, SN20410082, SN20410083, SN20410084, SN20410093, SN20410094, SN20410095, SN20410096, SN20410097, SN20410115, SN20410116, SN20410117, SN20410118, SN20410119, SN20410120, 20410154, SN20410171, SN20410172, SN20410202, SN20410218, SN20410219, SN20410242, SN20410260, SN20410261, SN20410279, SN20410280, SN20410288, SN20410289, SN20410290, SN20410291, SN20410298, SN20410299, SN20410300, SN20410313, SN20410321, SN20410334, SN20410360, SN20410367, SN20410373, SN20410395, SN20410396, SN20410428, SN20410472, SN20410473, SN20410482, SN20410566, SN20410567, SN20410570, SN21410017, SN21410034, SN21410035, SN21410048, SN21410060, SN21410061, SN21410062, SN21410081, SN21410093, SN21410094, SN21410103, SN21410104, SN21410105, 21410117, SN21410118, SN21410119, SN21410130, SN21410131, 21410132, SN21410133, SN21410149, SN21410150, SN21410153, SN21410154, SN21410155, SN21410169, SN21410170, SN21410171, SN21410172, SN21410187, SN21410188, SN21410189, SN21410190, SN21410200, SN21410201, SN21410203, SN21410204, SN21410205, SN21410206, SN21410207, SN21410208, SN21410212, 21410213, 21410214, SN21410232, SNZY20410009, SNZY20410011, SNZY20410014, SNZY204110015, 485059/SN11000013, 485060/SN11000015, 485062/SN11000009, 485061/SN11000012, 488170/SN11000010, 488169/SN11000011, 489089/SN11000016, 489694/SN11000035, 489696/SN11000037, 489616/SN11000033, 490027/SN11000034, 489695/SN11000036, 489088/SN11000040, 490221/SN11000039, 492411/SN11000014, 492417/SN11000048, 493565/SN11000048, 493566/SN11000047, 494456/SN11000055, 494941/SN11000052, 494464/SN11000065, 488171/SN11000068, 494864/SN11000060, 494865/SN11000056, 494866/SN11000062, 494867/SN11000051, 495286/SN11000061, 494060/SN11000070, 494061/SN11000071, 494062/SN11000072, 494064/SN11000074, 494065/SN11000075, 494063/SN11000073, 496446/SN11000082, 496448/SN11000057, 497570/SN11000066, 496387/SN12000003, 497715/SN11000080, 495938/SN12000007, 12000008, 493364/SN12000022, 493462/SN12000023, 500740/SN12000028, 501028/SN12000026, 500739/SN12000027, 502424/SN12000034, 503141/SN12000038, 503142/SN12000037, 503143/SN12000036, 503144/SN12000039, 503380/SN12000044, 502721/SN12000047, 505077/SN12000048, 500466/SN12000045, 506626/SN12000051, 507607/SN12000054, 507906/SN12000055, 508342/SN12000057, 496401/SN12000059, 500467/SN12000060, 500468/SN12000058, 508838/SN12000061, 508532/SN12000062, 504450/SN12000064, 509718/SN12000068, 509633/SN12000069, 509640/SN12000071, 510607/SN12000072, 512879/SN12000076, 512160/SN12000077, 513848/SN12000084, 512887/SN12000085, 512888/SN12000086, 512890/SN12000087, 512892/SN12000082, 508699/SN12000088, 514103/SN12000092, 514104/SN12000091, 514461/SN12000090, 514462/SN12000089, 513477/SN12000080, 513478/SN12000081, 516891/SN12000110, 516896/SN12000111, 509062/SN12000107, 497572/SN12000112, 508783/SN12000108, 518135/SN12000118, 518342/SN12000119, 518343/SN12000120, 518344/SN12000121, 518345/SN12000122, 518346/SN12000123, 502025/SN12000124, 502026/SN12000125, 519326/SN13000005, 519388/SN13000006, 519511/SN13000010, 519387/SN13000012, 519763/SN13000013, 519434/SN13000014, 519762/SN13000018, 520251/SN13000016, 519506/SN13000011, 520253/SN13000017, 520254/SN13000019, 520255/SN13000020, 520256/SN13000021, 520413/SN13000023, 520414/SN13000025, 520415/SN13000026, 520416/SN13000031, 520252/SN13000027, 520421/SN13000032, 520422/SN13000028, 520417/SN13000033, 520418/SN13000030, 522633/SN13000035, 522944/SN13000037, 523279/SN13000042, 523349/SN13000043, 13000046, 13000047, 13000048, 13000049, 13000053, 13000060, 13000054, 13000056, 13000058, 13000057, 13000055, SN13000074, 13000075, 13000070, 13000071, SN13000073, SN13000069, SN13000072, 13000077, 13000078, SN13000084, SN13000083, SN13000091, 13000090, SN13000104, SN13000107, SN13000106, SN13000102, 13000109, SN13000112, SN13000113, 519598/SN13000118, 519599/SN13000119, 519600/SN13000120, SN13000125, 13000127, 13000142, 13000141, 13000140, 13000139, 13000143, 13000144, SN13000147, SN13000154, SN13000153, 13000158, SN13000157, SN13000160, SN13000164, 13000177, 13000163, SN13000176, 13000165, SN13000174, SN13000180, SN13000183, SN13000185, SN13000182, 14000010, 13000199, 13000196, SN13000206, 13000203, 13000205, 13000204, 14000004, 14000005, 13000202, 14000006, 14000024, 14000022, 14000028, 14000032, 14000031, 14000029, 14000033, 14000034, 14000037, 14000038, 14000046, 14000048, 14000050, SN14000061, 14000069, 14000075, 14000072, 14000077, 14000080, 14000079, 14000081, 14000078, 14000084, 14000082, 14000086, 14000087, 14000088, 14000089, 14000043, SN14000098, SN14000099, SN14000100, 14000103, 14000106, 14000085, 14000112, 14000120, 14000121, 14000122, 14000124, 14000127, 14000092, SN14100071, SN14100072, SN14100073, SN14000130, SN14100074, SN14100075, SN14100047, 14100053, SN14100046, 14100044, 14100045, SN14100055, 14100054, 14000134, 14100087, 14100086, 14100088, 14100085, 14000135, 14100090, 14100097, 14100094, 14100095, 14100101, 14100109, 14100111, 14000138, 14000139, 14100117, 14100126, 14100128, 14100127, SN15100009, SN15100011, SN15100016, SN15100018, SN15100020, SN15000002, 15100023, 15100019, 15100034, 15100048, 15100047, 15100036, 15100035, 15100050, 15100028, 15100071, 15100039, 15100084, 15100085, 15100089, 15100088, 15100094, 15100091, 15100092, 15100087, 15100093, 15100098, 15100097, 15100099, 15100103, 15100101, 15100122, 15100121, 15100120, 15100119, 15100118, 15100128, 15100129, 15100117, 15100123, 15100130, 15100132, 15100139, 15100140, 15100137, 15100134, 15100136, SN15100150, SN15100148, SN15100149, SN15100153, SN15100030, SN15100151, SN15100158, SN15100155, SN15100157, 15100166, 15100162, 15100165, 15100169, 15100172, 15100171, 15100173, 15100178, 15100170, 15100161, 15100168, SN15100179, SN15100181, SN14000126, 15100195, 15100196, 15100211, 15100214, 15100219, 15100222, 15100223, 15100227, 15100228, 15100229, 15100230, 15100233, 15100238, 15100253, 15100249, SN15100255, SN15100260, 15100266, 15100268, 15100270, 15100271, 15100273, 15100275, 15100277, 16100005, 16100007, SN16100012, 16100028, 16100029, 16100033, 16100034, 16100041, 16100042, 16100045, 16100047, 16100049, 16100061, 16100062, 16100065, 16200010, 16200030, 16200033, 16200027, 16200034, 16200036, 16200045, 16200046, 16200052, 16200058, 16200059, 16200057, 16200043, 16200062, 16200063, 16200065, 16200069, 16200076, SN16200077, 16200078, 16200074, 16200075, 16200089, 16200085, 16200086, 16200087, 16200101, 16200102, 16200103, 16200107, 16200108, 16200135, 16200127, SN16200126, 16200138, 16200139, 16200140, 16200157, 16200152, 16200159, 17200003, 17200004, 17200005, 17200006, 17200011, 17200014, 17200019, 17200020, 17200024, 17200025, 17200027, 17200026, 17200033, 17200030, 17200032, 17200038, 17200043, 17200037, SN17200049, 17200058, 71573917, 17200060, 17200061, SN17200055, 17200059, SN17200066, SN17200067, SN17200072, SN17200083, SN17200082, SN17200084, SN17200087, 17200086, SN17200089, SN17200088, SN17200096, SN17200097, SN17200100, SN17200101, SN17200102, SN17200098, SN17200099, SN17200091, SN17200106, SN17200112, SN17200113, 17200114, SN17200115, SN17200121, SN17200123, SN17200126, SN17200125, SN17200130, SN17200129, SN17200128, SN17200127, SN17200134, SN17200135, SN17200138, SN17200137, SN17200139, SN17200136, SN17200152, SN17200160, SN17200159, SN17200158, SN17200177, SN17200176, SN17200172, SN17200171, SN17200157, SN17200166, 17200165, SN17200164, SN17200163, SN17200181, SN17200189, SN17200187, SN17200192, SN17200191, SN17200188, SN17200182, SN17200204, SN17200205, SN17200207, SN17200202, SN17200201, SN17200196, SN17200195, SN17200219, SN17200194, SN17200197, SN17200220, SN17200200, SN17200224, SN17200198, SN17200237, SN17200236, 17200235, SN17200239, SN18200009, SN18200008, SN18200007, 18200042, SN18200040, SN18200041, 8200039, SN18200013, SN18200036, 18200044, 18200031, 18200047, 18200033, SN18200037, 18200045, 18200046, 18200038, 18200048, SN18200034, SN18200012, SN18200043, SN18200058, SN18200059, SN18200032, SN18200061, SN18200057, 18200056, SN18200068, SN18200071, SN18200081, SN18200082, SN18200084, SN18200086, SN18200085, SN18200072, SN18200116, SN18200117, SN18200035, SN18200067, SN18200096, SN18200110, SN18000087, SN18200127, SN18200070, SN18200139, SN18200138, SN18200095, SN18200109, SN18200123, SN18200137, SN18200140, SN18200141, SN18200159, SN18200154, SN18200160, 18200171, SN18200169, SN18200161, SN18200167, SN18200166, SN18200165, SN18200173, SN18200175, SN18200174, SN18200183, SN18200185, SN18200187, SN18200208, SN18200203, SN18200205, SN18200206, SN18200189, SN18200194, SN18200211, SN18200215, SN18200200, SN18200216, SN18200217, SN18200218, SN18200219, SN18200222, SN18200231, SN18200244, SN18200210, SN18200232, SN18200233, SN18200234, SN18200254, SN18200256, SN18200257, SN18200261, SN18200259, SN18200258, SN18200271, SN18200260, SN18200288, SN18200292, SN18200310, SN18200315, SN18200314, SN18200245, SN18200332, SN18200334, SN18200236, SN18200237, SN18200335, SN18200337, SN18200344, SN18200343, SN19300001, SN19300002, SN19300030, SN19300007, SN19300023, SN19300026, SN19300032, SN19300033, SN19300040, SN19300043, SN19300028, SN19300024, SN19300063, SN19300044, SN19300066, SN19300067, SN19300016, SN19300070, SN19300076, SN19300075, SN19300074, SN19300072, SN19300005, SN19300077, 24410156, 24410155, 24410154, 24410153, 24410152, 24410150, 24410147, 24410145, 24410144, 24410143, 24410142, 24410141, 25410027, 25410026, 25410024, 25410023, 25410022, 25410021, 25410018, 25410017, 25410016, 25410015, 25410014, 25410013, 25410012, 25410011, 25410010, 25410009, 25410008, 25410007, 25410005, 25410004, 25410003, 25410002, 25410001, 24410185, 24410184, 24410183, 24410181, 24410180, 24410176, 24410175, 24410174, 24410172, 24410171, 24410170, 24410162, 24410161, 24410160, 24410035, 24410028, 24410025.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
SEDECAL SA
Reason for Recall:
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system

Product Codes/Lot Numbers:

UDI/DI 08436046002357, Serial Numbers: SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080, SN13000082, SN13000062, SN13000059, SN13000063, SN13000061, 13000067, 13000076, SN13000089, SN13000103, 13000085, SN13000146, 13000094, 13000092, 13000093, SN13000087, SN13000096, SN13000095, SN13000098, SN13000097, SN13000159, SN13000148, 13000145, 13000117, 14000051, SN13000149, 13000168, 14000015, 14000017, 14000014, 14000013, 14000019, 14000016, 13000167, 13000169, 14000011, 12000166, SN13000170, 13000200, 14000083, 14000008, 14000009, 13000201, SN13000179, SN13000181, 14000052, 14000026, 61918783, 14000049, 11000010, 13000068, 14000047, 14000041, 62072683, 62150154, 14000020, 62415613, SN14000097, SN14000096, 62587177, 14000116, 14000109, 14000119, 14000118, 14000126, 63604709, SN14000128, 64123668, 64216085, 14100105, 14100104, SN15100010, SN15100013, 15100104, 64904292, 15100100, 15100042, 15100040, 15100041, 15100226, 15100095, 65073897, 15100198, 15100116, 15100115, 15100127, 15100131, 15100135, 15100138, 15100144, 15100133, 14100034, SN14000127, 15100191, 66690596, 66936848, 15100274, 15100280, 15100276, SN16100008, 16100011, 67905914, 16100037, 16100038, 68025890, 68052381, 68054442, 68199970, 68233849, 68268597, 12000085, 68530038, 16200084, 16200028, 16200029, 16200049, 16200050, 16200051, 69022933, 16200064, 16200099, 70240554, 70378102, 70544668, 70545417, 70705340, 71001729, 72299716, 72555189, 21410094, 21410261, 21410347, 21410348, 22410146, 97579477, 97808946, 22410333, 17200007, 17200002, SN16200130, 16200129, 70929667, 16200137, 16200136, SN17200073, SN17200056, SN17200131, SN17200140, SN17200162, SN17200161, SN17200174, SN17200173, SN17200175, SN17200168, SN17200167, 16200049, SN17200217, 17200167, 17200168, SN18200010, SN18200011, SN18200049, SN18200088, SN18200112, SN18200133, SN18200124, 74854394, 75716470, SN18200176, SN18200186, SN18200209, SN18200341, 18200206, 18200205, SN19300073, SN19300085, SN19300098, 16, SN19300035, SN19300088, SN19300091, SN19300099, SN19300109, 23410012, SN21410184, SN19410126, 27, SN19410129, 23410046, 19410044, 19410046, 21410266, 21410280, 21410288, 21410290, 21410291, 21410293, 21410294, 21410320, 21410329, 21410330, 21410331, 21410332, 21410333, 21410334, 21410339, 21410340, 21410341, 21410342, 21410345, 21410349, 21410351, 21410360, 21410361, 21410362, 21410363, 21410365, 21410366, 21410367, 21410368, 21410369, 21410378, 21410379, 21410383, 21410384, 21410394, 21410402, 21410409, 21410410, 21410413, 21410414, 21410436, 22410002, 22410003, 22410021, 22410022, 22410023, 22410032, 22410033, 22410034, 22410035, 22410036, 22410050, 22410093, 22410121, 22410122, 22410132, 22410133, 22410142, 22410143, 22410145, 22410152, 22410153, 22410154, 22410155, 22410158, 22410159, 22410160, 22410161, 22410163, 22410164, 22410165, 22410189, 22410194, 22410195, 22410196, 22410197, 22410198, 22410199, 22410200, 22410201, 22410202, 22410203, 22410204, 22410218, 22410219, 22410226, 22410229, 22410236, 22410237, 22410238, 22410239, 22410245, 22410246, 22410247, 22410248, 22410251, 22410253, 22410315, 22410317, 22410318, 22410319, 22410320, 22410321, 22410322, 22410328, 22410331, 22410332, 23410008, 23410009, 23410010, 23410027, 23410040, 23410043, 23410044, 23410045, 23410047, 23410071, 23410072, 23410073, 23410078, 23410079, 23410080, 23410081, 23410086, 23410087, 23410088, 23410089, 23410090, 23410091, 23410092, 23410099, 23410102, 23410108, 23410120, 23410121, 23410122, 23410124, 23410125, 23410128, 23410133, 23410134, 23410135, 23410138, 23410139, 23410152, 23410164, 23410167, 23410171, 23410172, 23410174, 23410175, 23410176, 23410177, 23410193, 23410247, 23410257, 23410269, 23410270, 24410107, 24410146, 24410148, 24410149, 24410151, 24410168, 214410346, 214411180, 214411229, 23410118, SN0410157, SN1410049, SN19410034, SN19410035, SN19410037, SN19410071, SN19410092, SN19410093, SN19410094, SN19410097, SN19410098, SN19410099, SN19410100, SN19410101, SN19410102, SN19410115, SN19410116, SN19410123, SN19410127, SN19410135, SN19410136, SN19410137, SN20410029, SN20410030, SN20410032, SN20410033, SN20410034, SN20410044, SN20410045, SN20410049, SN20410060, SN20410063, SN20410064, SN20410065, SN20410066, SN20410071, SN20410072, SN20410073, SN20410074, SN20410081, SN20410082, SN20410083, SN20410084, SN20410093, SN20410094, SN20410095, SN20410096, SN20410097, SN20410115, SN20410116, SN20410117, SN20410118, SN20410119, SN20410120, 20410154, SN20410171, SN20410172, SN20410202, SN20410218, SN20410219, SN20410242, SN20410260, SN20410261, SN20410279, SN20410280, SN20410288, SN20410289, SN20410290, SN20410291, SN20410298, SN20410299, SN20410300, SN20410313, SN20410321, SN20410334, SN20410360, SN20410367, SN20410373, SN20410395, SN20410396, SN20410428, SN20410472, SN20410473, SN20410482, SN20410566, SN20410567, SN20410570, SN21410017, SN21410034, SN21410035, SN21410048, SN21410060, SN21410061, SN21410062, SN21410081, SN21410093, SN21410094, SN21410103, SN21410104, SN21410105, 21410117, SN21410118, SN21410119, SN21410130, SN21410131, 21410132, SN21410133, SN21410149, SN21410150, SN21410153, SN21410154, SN21410155, SN21410169, SN21410170, SN21410171, SN21410172, SN21410187, SN21410188, SN21410189, SN21410190, SN21410200, SN21410201, SN21410203, SN21410204, SN21410205, SN21410206, SN21410207, SN21410208, SN21410212, 21410213, 21410214, SN21410232, SNZY20410009, SNZY20410011, SNZY20410014, SNZY204110015, 485059/SN11000013, 485060/SN11000015, 485062/SN11000009, 485061/SN11000012, 488170/SN11000010, 488169/SN11000011, 489089/SN11000016, 489694/SN11000035, 489696/SN11000037, 489616/SN11000033, 490027/SN11000034, 489695/SN11000036, 489088/SN11000040, 490221/SN11000039, 492411/SN11000014, 492417/SN11000048, 493565/SN11000048, 493566/SN11000047, 494456/SN11000055, 494941/SN11000052, 494464/SN11000065, 488171/SN11000068, 494864/SN11000060, 494865/SN11000056, 494866/SN11000062, 494867/SN11000051, 495286/SN11000061, 494060/SN11000070, 494061/SN11000071, 494062/SN11000072, 494064/SN11000074, 494065/SN11000075, 494063/SN11000073, 496446/SN11000082, 496448/SN11000057, 497570/SN11000066, 496387/SN12000003, 497715/SN11000080, 495938/SN12000007, 12000008, 493364/SN12000022, 493462/SN12000023, 500740/SN12000028, 501028/SN12000026, 500739/SN12000027, 502424/SN12000034, 503141/SN12000038, 503142/SN12000037, 503143/SN12000036, 503144/SN12000039, 503380/SN12000044, 502721/SN12000047, 505077/SN12000048, 500466/SN12000045, 506626/SN12000051, 507607/SN12000054, 507906/SN12000055, 508342/SN12000057, 496401/SN12000059, 500467/SN12000060, 500468/SN12000058, 508838/SN12000061, 508532/SN12000062, 504450/SN12000064, 509718/SN12000068, 509633/SN12000069, 509640/SN12000071, 510607/SN12000072, 512879/SN12000076, 512160/SN12000077, 513848/SN12000084, 512887/SN12000085, 512888/SN12000086, 512890/SN12000087, 512892/SN12000082, 508699/SN12000088, 514103/SN12000092, 514104/SN12000091, 514461/SN12000090, 514462/SN12000089, 513477/SN12000080, 513478/SN12000081, 516891/SN12000110, 516896/SN12000111, 509062/SN12000107, 497572/SN12000112, 508783/SN12000108, 518135/SN12000118, 518342/SN12000119, 518343/SN12000120, 518344/SN12000121, 518345/SN12000122, 518346/SN12000123, 502025/SN12000124, 502026/SN12000125, 519326/SN13000005, 519388/SN13000006, 519511/SN13000010, 519387/SN13000012, 519763/SN13000013, 519434/SN13000014, 519762/SN13000018, 520251/SN13000016, 519506/SN13000011, 520253/SN13000017, 520254/SN13000019, 520255/SN13000020, 520256/SN13000021, 520413/SN13000023, 520414/SN13000025, 520415/SN13000026, 520416/SN13000031, 520252/SN13000027, 520421/SN13000032, 520422/SN13000028, 520417/SN13000033, 520418/SN13000030, 522633/SN13000035, 522944/SN13000037, 523279/SN13000042, 523349/SN13000043, 13000046, 13000047, 13000048, 13000049, 13000053, 13000060, 13000054, 13000056, 13000058, 13000057, 13000055, SN13000074, 13000075, 13000070, 13000071, SN13000073, SN13000069, SN13000072, 13000077, 13000078, SN13000084, SN13000083, SN13000091, 13000090, SN13000104, SN13000107, SN13000106, SN13000102, 13000109, SN13000112, SN13000113, 519598/SN13000118, 519599/SN13000119, 519600/SN13000120, SN13000125, 13000127, 13000142, 13000141, 13000140, 13000139, 13000143, 13000144, SN13000147, SN13000154, SN13000153, 13000158, SN13000157, SN13000160, SN13000164, 13000177, 13000163, SN13000176, 13000165, SN13000174, SN13000180, SN13000183, SN13000185, SN13000182, 14000010, 13000199, 13000196, SN13000206, 13000203, 13000205, 13000204, 14000004, 14000005, 13000202, 14000006, 14000024, 14000022, 14000028, 14000032, 14000031, 14000029, 14000033, 14000034, 14000037, 14000038, 14000046, 14000048, 14000050, SN14000061, 14000069, 14000075, 14000072, 14000077, 14000080, 14000079, 14000081, 14000078, 14000084, 14000082, 14000086, 14000087, 14000088, 14000089, 14000043, SN14000098, SN14000099, SN14000100, 14000103, 14000106, 14000085, 14000112, 14000120, 14000121, 14000122, 14000124, 14000127, 14000092, SN14100071, SN14100072, SN14100073, SN14000130, SN14100074, SN14100075, SN14100047, 14100053, SN14100046, 14100044, 14100045, SN14100055, 14100054, 14000134, 14100087, 14100086, 14100088, 14100085, 14000135, 14100090, 14100097, 14100094, 14100095, 14100101, 14100109, 14100111, 14000138, 14000139, 14100117, 14100126, 14100128, 14100127, SN15100009, SN15100011, SN15100016, SN15100018, SN15100020, SN15000002, 15100023, 15100019, 15100034, 15100048, 15100047, 15100036, 15100035, 15100050, 15100028, 15100071, 15100039, 15100084, 15100085, 15100089, 15100088, 15100094, 15100091, 15100092, 15100087, 15100093, 15100098, 15100097, 15100099, 15100103, 15100101, 15100122, 15100121, 15100120, 15100119, 15100118, 15100128, 15100129, 15100117, 15100123, 15100130, 15100132, 15100139, 15100140, 15100137, 15100134, 15100136, SN15100150, SN15100148, SN15100149, SN15100153, SN15100030, SN15100151, SN15100158, SN15100155, SN15100157, 15100166, 15100162, 15100165, 15100169, 15100172, 15100171, 15100173, 15100178, 15100170, 15100161, 15100168, SN15100179, SN15100181, SN14000126, 15100195, 15100196, 15100211, 15100214, 15100219, 15100222, 15100223, 15100227, 15100228, 15100229, 15100230, 15100233, 15100238, 15100253, 15100249, SN15100255, SN15100260, 15100266, 15100268, 15100270, 15100271, 15100273, 15100275, 15100277, 16100005, 16100007, SN16100012, 16100028, 16100029, 16100033, 16100034, 16100041, 16100042, 16100045, 16100047, 16100049, 16100061, 16100062, 16100065, 16200010, 16200030, 16200033, 16200027, 16200034, 16200036, 16200045, 16200046, 16200052, 16200058, 16200059, 16200057, 16200043, 16200062, 16200063, 16200065, 16200069, 16200076, SN16200077, 16200078, 16200074, 16200075, 16200089, 16200085, 16200086, 16200087, 16200101, 16200102, 16200103, 16200107, 16200108, 16200135, 16200127, SN16200126, 16200138, 16200139, 16200140, 16200157, 16200152, 16200159, 17200003, 17200004, 17200005, 17200006, 17200011, 17200014, 17200019, 17200020, 17200024, 17200025, 17200027, 17200026, 17200033, 17200030, 17200032, 17200038, 17200043, 17200037, SN17200049, 17200058, 71573917, 17200060, 17200061, SN17200055, 17200059, SN17200066, SN17200067, SN17200072, SN17200083, SN17200082, SN17200084, SN17200087, 17200086, SN17200089, SN17200088, SN17200096, SN17200097, SN17200100, SN17200101, SN17200102, SN17200098, SN17200099, SN17200091, SN17200106, SN17200112, SN17200113, 17200114, SN17200115, SN17200121, SN17200123, SN17200126, SN17200125, SN17200130, SN17200129, SN17200128, SN17200127, SN17200134, SN17200135, SN17200138, SN17200137, SN17200139, SN17200136, SN17200152, SN17200160, SN17200159, SN17200158, SN17200177, SN17200176, SN17200172, SN17200171, SN17200157, SN17200166, 17200165, SN17200164, SN17200163, SN17200181, SN17200189, SN17200187, SN17200192, SN17200191, SN17200188, SN17200182, SN17200204, SN17200205, SN17200207, SN17200202, SN17200201, SN17200196, SN17200195, SN17200219, SN17200194, SN17200197, SN17200220, SN17200200, SN17200224, SN17200198, SN17200237, SN17200236, 17200235, SN17200239, SN18200009, SN18200008, SN18200007, 18200042, SN18200040, SN18200041, 8200039, SN18200013, SN18200036, 18200044, 18200031, 18200047, 18200033, SN18200037, 18200045, 18200046, 18200038, 18200048, SN18200034, SN18200012, SN18200043, SN18200058, SN18200059, SN18200032, SN18200061, SN18200057, 18200056, SN18200068, SN18200071, SN18200081, SN18200082, SN18200084, SN18200086, SN18200085, SN18200072, SN18200116, SN18200117, SN18200035, SN18200067, SN18200096, SN18200110, SN18000087, SN18200127, SN18200070, SN18200139, SN18200138, SN18200095, SN18200109, SN18200123, SN18200137, SN18200140, SN18200141, SN18200159, SN18200154, SN18200160, 18200171, SN18200169, SN18200161, SN18200167, SN18200166, SN18200165, SN18200173, SN18200175, SN18200174, SN18200183, SN18200185, SN18200187, SN18200208, SN18200203, SN18200205, SN18200206, SN18200189, SN18200194, SN18200211, SN18200215, SN18200200, SN18200216, SN18200217, SN18200218, SN18200219, SN18200222, SN18200231, SN18200244, SN18200210, SN18200232, SN18200233, SN18200234, SN18200254, SN18200256, SN18200257, SN18200261, SN18200259, SN18200258, SN18200271, SN18200260, SN18200288, SN18200292, SN18200310, SN18200315, SN18200314, SN18200245, SN18200332, SN18200334, SN18200236, SN18200237, SN18200335, SN18200337, SN18200344, SN18200343, SN19300001, SN19300002, SN19300030, SN19300007, SN19300023, SN19300026, SN19300032, SN19300033, SN19300040, SN19300043, SN19300028, SN19300024, SN19300063, SN19300044, SN19300066, SN19300067, SN19300016, SN19300070, SN19300076, SN19300075, SN19300074, SN19300072, SN19300005, SN19300077, 24410156, 24410155, 24410154, 24410153, 24410152, 24410150, 24410147, 24410145, 24410144, 24410143, 24410142, 24410141, 25410027, 25410026, 25410024, 25410023, 25410022, 25410021, 25410018, 25410017, 25410016, 25410015, 25410014, 25410013, 25410012, 25410011, 25410010, 25410009, 25410008, 25410007, 25410005, 25410004, 25410003, 25410002, 25410001, 24410185, 24410184, 24410183, 24410181, 24410180, 24410176, 24410175, 24410174, 24410172, 24410171, 24410170, 24410162, 24410161, 24410160, 24410035, 24410028, 24410025.

Distribution:

Distributed in: US, CA, IL, NJ

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0243-2026

Related Recalls

Model Number 40KWFXPLUS.004, Mobile X-ray system

SEDECAL SA

Class I - Dangerous

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Jun 10, 2025 Other Medical Devices View Details →