MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number: 11060815. 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Serial Numbers: 176636, 177211, 175728, 175685, 175851, 175768, 177298, 177295, 176756, 175754, 177349, 176757, 177232, 175935, 176967, 175741, 177052, 176060, 176371, 177012, 177146, 175770, 176375, 176122, 176308, 175669, 176212, 176755, 176781, 176302, 176036, 175766, 176825, 177151, 176087, 176771, 177299, 176451, 177352, 177354, 176779, 175870, 175838, 175692, 177359, 177119, 175977, 176037, 177244, 176686, 175831, 177096, 176660, 177034, 176639, 176397, 175805, 176358, 176293, 176118, 175681, 177088, 177035, 176093, 176189, 177337, 177333, 176094, 176736, 177105, 177007, 175787, 177381, 176027, 176340, 177144, 176258, 176363, 176561, 176665, 176577, 176572, 176559, 176696, 176452, 176081, 175853, 175893, 177033, 177392, 177116, 177124, 175897, 175883, 177329, 176567, 175640, 176033, 176316, 176529, 176219, 176254, 176865, 176709, 176059, 175829, 175706, 176635, 175903, 176374, 176217, 176832, 175834, 175655, 175660, 176630, 177258, 177162, 176661, 177371, 176829, 175907, 176956, 177213, 176570, 176532, 177257, 177262, 176319, 175850, 176332, 176096, 176492, 177265, 176654, 177332, 176092, 177356, 176288, 175765, 176350, 176751, 176038, 176437, 177319, 176086, 177347, 175976, 177125, 176391, 176828, 176814, 176030, 177086, 176813, 177118, 176433, 176594, 177159, 175825, 176414, 177178, 177238, 177123, 176962, 176211, 177102, 176843, 176102, 177366, 176000, 176483, 176048, 177209, 176906, 175734, 175964, 175682, 175650, 175651, 175625, 175656, 175875, 175843, 175721, 176002, 177324, 176831, 177402, 176459, 176658, 176101, 176203, 175676, 175866, 177309, 176084, 177312, 175695, 176130, 175661, 175920, 175737, 175847, 177289, 177283, 177293, 175819, 176948, 176637, 176176, 177143, 176519, 176733, 177214, 176607, 176238, 175849, 176261, 177346, 177345, 176667, 177210, 175979, 176328, 176333, 176336, 177237, 177136, 176811, 176312, 175915, 176537, 177398, 177149, 177216, 177217, 175700, 176137, 175639, 175922, 175873, 175774, 177276, 176186, 176573, 176069, 176341, 176449, 176420, 176677, 176874, 176969, 176652, 176927, 175740, 177339, 175912, 176168, 175982, 176508, 176091, 175701, 175624, 175671, 175673, 175672, 176011, 176139, 176010, 176259, 176877, 176880, 176876, 176159, 176683, 176526, 176958, 177203, 177383, 175616, 177155, 175954, 176676, 175914, 176544, 177104, 177234, 176393, 175803, 176287, 177160, 176299, 176788, 177331, 177253, 175615, 176239, 177170, 177336, 177334, 176732, 177303, 175716, 175876, 176004, 177184, 176218, 175634, 177181, 175990, 176405, 177150, 177072, 176524, 177361, 176119, 176586, 177374, 176326, 176868, 176475, 175830, 175611, 175820, 177259, 176169, 177205, 177286, 176546, 176550, 175810, 177384, 176354, 176246, 176204, 176465, 177109, 176021, 175633, 176020, 177061, 176127, 176888, 176596, 177318, 175761, 176146, 177031, 176184, 177397, 176348, 176251, 176691, 175731, 177348, 177011, 176533, 176555, 177107, 175760, 176120, 176083, 176229, 177363, 175869, 177292, 177172, 177173, 176731, 176194, 176248, 175839, 175986, 175663, 176161, 176939, 176700, 176271, 176930, 177279, 176563, 176837, 176849, 177368, 177380, 176790, 176054, 176445, 175872, 175777, 176560, 177133, 176651, 176377, 176376, 176196, 176195, 175647, 175807, 175627, 175629, 176068, 176064, 175816, 175814, 177275, 177273, 176450, 176578, 175772, 175779, 177278, 177270, 177267, 177281, 176053, 177239, 176953, 175786, 176815, 175894, 176735, 176994, 177055, 175993, 176057, 175775, 177032, 176512, 175691, 176545, 177220, 177037, 177285, 176944, 176047, 177145, 175965, 175635, 175746, 176072, 175654, 176294, 176089, 176085, 176522, 177189, 175689, 177338, 176178, 176541, 176759, 176142, 175919, 177098, 176202, 176689, 177280, 177229, 176548, 177230, 177231, 176852, 176502, 176282, 175881, 176912, 176058, 175738, 175657, 175705, 175758, 177054, 177386, 176754, 176925, 177255, 176457, 177256, 177127, 175614, 177164, 176486, 176438, 176157, 176995, 177323, 176410, 176680, 176518, 175941, 175618, 176364, 175801, 175822, 176040, 175643.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Siemens Medical Solutions USA, Inc
- Reason for Recall:
- There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
Product Codes/Lot Numbers:
Model Number: 11060815. UDI Numbers: (01)04056869039176(21)176636, (01)04056869039176(21)177211, (01)04056869039176(21)175728, (01)04056869039176(21)175685, (01)04056869039176(21)175851, (01)04056869039176(21)175768, (01)04056869039176(21)177298, (01)04056869039176(21)177295, (01)04056869039176(21)176756, (01)04056869039176(21)175754, (01)04056869039176(21)177349, (01)04056869039176(21)176757, (01)04056869039176(21)177232, (01)04056869039176(21)175935, (01)04056869039176(21)176967, (01)04056869039176(21)175741, (01)04056869039176(21)177052, (01)04056869039176(21)176060, (01)04056869039176(21)176371, (01)04056869039176(21)177012, (01)04056869039176(21)177146, (01)04056869039176(21)175770, (01)04056869039176(21)176375, (01)04056869039176(21)176122, (01)04056869039176(21)176308, (01)04056869039176(21)175669, (01)04056869039176(21)176212, (01)04056869039176(21)176755, (01)04056869039176(21)176781, (01)04056869039176(21)176302, (01)04056869039176(21)176036, (01)04056869039176(21)175766, 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(01)04056869039176(21)176083, (01)04056869039176(21)176229, (01)04056869039176(21)177363, (01)04056869039176(21)175869, (01)04056869039176(21)177292, (01)04056869039176(21)177172, (01)04056869039176(21)177173, (01)04056869039176(21)176731, (01)04056869039176(21)176194, (01)04056869039176(21)176248, (01)04056869039176(21)175839, (01)04056869039176(21)175986, (01)04056869039176(21)175663, (01)04056869039176(21)176161, (01)04056869039176(21)176939, (01)04056869039176(21)176700, (01)04056869039176(21)176271, (01)04056869039176(21)176930, (01)04056869039176(21)177279, (01)04056869039176(21)176563, (01)04056869039176(21)176837, (01)04056869039176(21)176849, (01)04056869039176(21)177368, (01)04056869039176(21)177380, (01)04056869039176(21)176790, (01)04056869039176(21)176054, (01)04056869039176(21)176445, (01)04056869039176(21)175872, (01)04056869039176(21)175777, (01)04056869039176(21)176560, (01)04056869039176(21)177133, (01)04056869039176(21)176651, (01)04056869039176(21)176377, (01)04056869039176(21)176376, (01)04056869039176(21)176196, (01)04056869039176(21)176195, (01)04056869039176(21)175647, (01)04056869039176(21)175807, (01)04056869039176(21)175627, (01)04056869039176(21)175629, (01)04056869039176(21)176068, (01)04056869039176(21)176064, (01)04056869039176(21)175816, (01)04056869039176(21)175814, (01)04056869039176(21)177275, (01)04056869039176(21)177273, (01)04056869039176(21)176450, (01)04056869039176(21)176578, (01)04056869039176(21)175772, (01)04056869039176(21)175779, (01)04056869039176(21)177278, (01)04056869039176(21)177270, (01)04056869039176(21)177267, (01)04056869039176(21)177281, (01)04056869039176(21)176053, (01)04056869039176(21)177239, (01)04056869039176(21)176953, (01)04056869039176(21)175786, (01)04056869039176(21)176815, (01)04056869039176(21)175894, (01)04056869039176(21)176735, (01)04056869039176(21)176994, (01)04056869039176(21)177055, (01)04056869039176(21)175993, (01)04056869039176(21)176057, (01)04056869039176(21)175775, (01)04056869039176(21)177032, (01)04056869039176(21)176512, (01)04056869039176(21)175691, (01)04056869039176(21)176545, (01)04056869039176(21)177220, (01)04056869039176(21)177037, (01)04056869039176(21)177285, (01)04056869039176(21)176944, (01)04056869039176(21)176047, (01)04056869039176(21)177145, (01)04056869039176(21)175965, (01)04056869039176(21)175635, (01)04056869039176(21)175746, (01)04056869039176(21)176072, (01)04056869039176(21)175654, (01)04056869039176(21)176294, (01)04056869039176(21)176089, (01)04056869039176(21)176085, (01)04056869039176(21)176522, (01)04056869039176(21)177189, (01)04056869039176(21)175689, (01)04056869039176(21)177338, (01)04056869039176(21)176178, (01)04056869039176(21)176541, (01)04056869039176(21)176759, (01)04056869039176(21)176142, (01)04056869039176(21)175919, (01)04056869039176(21)177098, (01)04056869039176(21)176202, (01)04056869039176(21)176689, (01)04056869039176(21)177280, (01)04056869039176(21)177229, (01)04056869039176(21)176548, (01)04056869039176(21)177230, (01)04056869039176(21)177231, (01)04056869039176(21)176852, (01)04056869039176(21)176502, (01)04056869039176(21)176282, (01)04056869039176(21)175881, (01)04056869039176(21)176912, (01)04056869039176(21)176058, (01)04056869039176(21)175738, (01)04056869039176(21)175657, (01)04056869039176(21)175705, (01)04056869039176(21)175758, (01)04056869039176(21)177054, (01)04056869039176(21)177386, (01)04056869039176(21)176754, (01)04056869039176(21)176925, (01)04056869039176(21)177255, (01)04056869039176(21)176457, (01)04056869039176(21)177256, (01)04056869039176(21)177127, (01)04056869039176(21)175614, (01)04056869039176(21)177164, (01)04056869039176(21)176486, (01)04056869039176(21)176438, (01)04056869039176(21)176157, (01)04056869039176(21)176995, (01)04056869039176(21)177323, (01)04056869039176(21)176410, (01)04056869039176(21)176680, (01)04056869039176(21)176518, (01)04056869039176(21)175941, (01)04056869039176(21)175618, (01)04056869039176(21)176364, (01)04056869039176(21)175801, (01)04056869039176(21)175822, (01)04056869039176(21)176040, (01)04056869039176(21)175643. Serial Numbers: 176636, 177211, 175728, 175685, 175851, 175768, 177298, 177295, 176756, 175754, 177349, 176757, 177232, 175935, 176967, 175741, 177052, 176060, 176371, 177012, 177146, 175770, 176375, 176122, 176308, 175669, 176212, 176755, 176781, 176302, 176036, 175766, 176825, 177151, 176087, 176771, 177299, 176451, 177352, 177354, 176779, 175870, 175838, 175692, 177359, 177119, 175977, 176037, 177244, 176686, 175831, 177096, 176660, 177034, 176639, 176397, 175805, 176358, 176293, 176118, 175681, 177088, 177035, 176093, 176189, 177337, 177333, 176094, 176736, 177105, 177007, 175787, 177381, 176027, 176340, 177144, 176258, 176363, 176561, 176665, 176577, 176572, 176559, 176696, 176452, 176081, 175853, 175893, 177033, 177392, 177116, 177124, 175897, 175883, 177329, 176567, 175640, 176033, 176316, 176529, 176219, 176254, 176865, 176709, 176059, 175829, 175706, 176635, 175903, 176374, 176217, 176832, 175834, 175655, 175660, 176630, 177258, 177162, 176661, 177371, 176829, 175907, 176956, 177213, 176570, 176532, 177257, 177262, 176319, 175850, 176332, 176096, 176492, 177265, 176654, 177332, 176092, 177356, 176288, 175765, 176350, 176751, 176038, 176437, 177319, 176086, 177347, 175976, 177125, 176391, 176828, 176814, 176030, 177086, 176813, 177118, 176433, 176594, 177159, 175825, 176414, 177178, 177238, 177123, 176962, 176211, 177102, 176843, 176102, 177366, 176000, 176483, 176048, 177209, 176906, 175734, 175964, 175682, 175650, 175651, 175625, 175656, 175875, 175843, 175721, 176002, 177324, 176831, 177402, 176459, 176658, 176101, 176203, 175676, 175866, 177309, 176084, 177312, 175695, 176130, 175661, 175920, 175737, 175847, 177289, 177283, 177293, 175819, 176948, 176637, 176176, 177143, 176519, 176733, 177214, 176607, 176238, 175849, 176261, 177346, 177345, 176667, 177210, 175979, 176328, 176333, 176336, 177237, 177136, 176811, 176312, 175915, 176537, 177398, 177149, 177216, 177217, 175700, 176137, 175639, 175922, 175873, 175774, 177276, 176186, 176573, 176069, 176341, 176449, 176420, 176677, 176874, 176969, 176652, 176927, 175740, 177339, 175912, 176168, 175982, 176508, 176091, 175701, 175624, 175671, 175673, 175672, 176011, 176139, 176010, 176259, 176877, 176880, 176876, 176159, 176683, 176526, 176958, 177203, 177383, 175616, 177155, 175954, 176676, 175914, 176544, 177104, 177234, 176393, 175803, 176287, 177160, 176299, 176788, 177331, 177253, 175615, 176239, 177170, 177336, 177334, 176732, 177303, 175716, 175876, 176004, 177184, 176218, 175634, 177181, 175990, 176405, 177150, 177072, 176524, 177361, 176119, 176586, 177374, 176326, 176868, 176475, 175830, 175611, 175820, 177259, 176169, 177205, 177286, 176546, 176550, 175810, 177384, 176354, 176246, 176204, 176465, 177109, 176021, 175633, 176020, 177061, 176127, 176888, 176596, 177318, 175761, 176146, 177031, 176184, 177397, 176348, 176251, 176691, 175731, 177348, 177011, 176533, 176555, 177107, 175760, 176120, 176083, 176229, 177363, 175869, 177292, 177172, 177173, 176731, 176194, 176248, 175839, 175986, 175663, 176161, 176939, 176700, 176271, 176930, 177279, 176563, 176837, 176849, 177368, 177380, 176790, 176054, 176445, 175872, 175777, 176560, 177133, 176651, 176377, 176376, 176196, 176195, 175647, 175807, 175627, 175629, 176068, 176064, 175816, 175814, 177275, 177273, 176450, 176578, 175772, 175779, 177278, 177270, 177267, 177281, 176053, 177239, 176953, 175786, 176815, 175894, 176735, 176994, 177055, 175993, 176057, 175775, 177032, 176512, 175691, 176545, 177220, 177037, 177285, 176944, 176047, 177145, 175965, 175635, 175746, 176072, 175654, 176294, 176089, 176085, 176522, 177189, 175689, 177338, 176178, 176541, 176759, 176142, 175919, 177098, 176202, 176689, 177280, 177229, 176548, 177230, 177231, 176852, 176502, 176282, 175881, 176912, 176058, 175738, 175657, 175705, 175758, 177054, 177386, 176754, 176925, 177255, 176457, 177256, 177127, 175614, 177164, 176486, 176438, 176157, 176995, 177323, 176410, 176680, 176518, 175941, 175618, 176364, 175801, 175822, 176040, 175643.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2667-2025
Related Recalls
MAMMOMAT Inspiration;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Fusion;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Revelation;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.