ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No. CLLE-0229; UDI: (01)01547410297546(11)210701(21)16724035, (01)045474100297546(11)191001(21)967022860, (01)045474100297546(11)191001(21)97022857, (01)045474100297546(11)191001(21)97022858, (01)045474100297546(11)191001(21)97022861, (01)04547410294546(11)190801(21)96822763, (01)04547410294546(11)190801(21)96822764, (01)04547410294546(11)190801(21)96822765, (01)04547410294546(11)190801(21)96822767, (01)04547410294576(11)210501(21)16523949, (01)04547410294576(11)210501(21)16523950, (01)04547410294576(11)210601(21)16623962, (01)04547410294576(11)210601(21)16623963, (01)04547410297546(01)170601(21)76621287, (01)04547410297546(11)000100(21)67121008, (01)04547410297546(11)160107(21)66120675, (01)04547410297546(11)170201(21)76221098, (01)04547410297546(11)170220(21)67121004, (01)04547410297546(11)170301(21)76321131, (01)04547410297546(11)170301(21)76321132, (01)04547410297546(11)170301(21)76321136, (01)04547410297546(11)170501(21)76521235, 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(01)04547410297546(11)190109(21)77221600, (01)04547410297546(11)190215(21)86221736, (01)04547410297546(11)190426(21)86421849, (01)04547410297546(11)190523(21)86221735, (01)04547410297546(11)190605(21)86622007, (01)04547410297546(11)190607(21)67121009, (01)04547410297546(11)190614(21)87022245, (01)04547410297546(11)190716(21)86622008, (01)04547410297546(11)190801(21)96822766, (01)04547410297546(11)190801(21)96822768, (01)04547410297546(11)190801(21)96822769, (01)04547410297546(11)190802(21)96522600, (01)04547410297546(11)190805(21)96422570, (01)04547410297546(11)190816(21)67121002, (01)04547410297546(11)190823(21)96522602, (01)04547410297546(11)190901(21)96622828, (01)04547410297546(11)190901(21)96922826, (01)04547410297546(11)190901(21)96922827, (01)04547410297546(11)190901(21)96922829, (01)04547410297546(11)190901(21)96922830, (01)04547410297546(11)190901(21)96922834, (01)04547410297546(11)191001(21)97022856, (01)04547410297546(11)191001(21)97022859, (01)04547410297546(11)191004(21)96622652, (01)04547410297546(11)191004(21)96622653, (01)04547410297546(11)191029(21)67121006, (01)04547410297546(11)191101(21)97122920, (01)04547410297546(11)191101(21)97122921, (01)04547410297546(11)191101(21)97122922, (01)04547410297546(11)191101(21)97122923, (01)04547410297546(11)191101(21)97122924, (01)04547410297546(11)191101(21)97122925, (01)04547410297546(11)191101(21)97122926, (01)04547410297546(11)191101(21)97122927, (01)04547410297546(11)191101(21)97122929, (01)04547410297546(11)191101(21)97122930, (01)04547410297546(11)191101(21)97122931, (01)04547410297546(11)191101(21)97122932, (01)04547410297546(11)191201(21)97222975, (01)04547410297546(11)191201(21)97222976, (01)04547410297546(11)191201(21)97222977, (01)04547410297546(11)191201(21)97222978, (01)04547410297546(11)191201(21)97222979, (01)04547410297546(11)191201(21)97222980, (01)04547410297546(11)191201(21)97222981, (01)04547410297546(11)191201(21)97222982, (01)04547410297546(11)191201(21)97222983, (01)04547410297546(11)191201(21)97222984, (01)04547410297546(11)191201(21)97222985, (01)04547410297546(11)191201(21)97222986, (01)04547410297546(11)191201(21)97222987, (01)04547410297546(11)191201(21)97222988, (01)04547410297546(11)191206(21)96522599, (01)04547410297546(11)191216(21)87022244, (01)04547410297546(11)200101(21)06123029, (01)04547410297546(11)200101(21)06123031, (01)04547410297546(11)200101(21)06123034, (01)04547410297546(11)200101(21)06123035, (01)04547410297546(11)200101(21)06123036, (01)04547410297546(11)200101(21)06123037, (01)04547410297546(11)200101(21)06123038, (01)04547410297546(11)200101(21)06123039, (01)04547410297546(11)200101(21)06123040, (01)04547410297546(11)200201(21)06223076, (01)04547410297546(11)200201(21)06223077, (01)04547410297546(11)200201(21)06223078, (01)04547410297546(11)200201(21)06223079, (01)04547410297546(11)200201(21)06223080, (01)04547410297546(11)200201(21)06223081, (01)04547410297546(11)200201(21)06223082, (01)04547410297546(11)200201(21)06223083, (01)04547410297546(11)200201(21)06223084, (01)04547410297546(11)200201(21)06223085, (01)04547410297546(11)200201(21)06223086, (01)04547410297546(11)200201(21)06223087, (01)04547410297546(11)200301(21)06323188, (01)04547410297546(11)200301(21)06323189, (01)04547410297546(11)200401(21)06423194, (01)04547410297546(11)200401(21)06423195, (01)04547410297546(11)200401(21)06423196, (01)04547410297546(11)200401(21)06423197, (01)04547410297546(11)200401(21)06423198, (01)04547410297546(11)200401(21)06423199, (01)04547410297546(11)200401(21)06423200, (01)04547410297546(11)200401(21)06423201, (01)04547410297546(11)200501(21)06423202, (01)04547410297546(11)200501(21)06523263, (01)04547410297546(11)200501(21)06523264, (01)04547410297546(11)200501(21)06523265, (01)04547410297546(11)200501(21)06523266, (01)04547410297546(11)200501(21)06523268, (01)04547410297546(11)200501(21)06523269, (01)04547410297546(11)200501(21)06523270, (01)04547410297546(11)200601(21)06623347, (01)04547410297546(11)200601(21)06623348, (01)04547410297546(11)200601(21)06623350, (01)04547410297546(11)200601(21)06623351, (01)04547410297546(11)200601(21)06623352, (01)04547410297546(11)200601(21)06623353, (01)04547410297546(11)200910(21)86221737, (01)04547410297546(11)201218(21)97122928, (01)04547410297546(11)210201(21)16223805, (01)04547410297546(11)210226(21)86521911, (01)04547410297546(11)210301(21)16323843, (01)04547410297546(11)210301(21)16323844, (01)04547410297546(11)210323(21)96522601, (01)04547410297546(11)210519(21)87022243, (01)04547410297546(11)210601(21)16623964, (01)04547410297546(11)210601(21)16623965, (01)04547410297546(11)210601(21)16623966, (01)04547410297546(11)210601(21)16623967, (01)04547410297546(11)210601(21)16623968, (01)04547410297546(11)210701(21)16724027, (01)04547410297546(11)210701(21)16724028, (01)04547410297546(11)210701(21)16724031, (01)04547410297546(11)210701(21)16724032, (01)04547410297546(11)210701(21)16724033, (01)04547410297546(11)210701(21)16724034, (01)04547410297546(11)210801(21)16824048, (01)04547410297546(11)210801(21)16824049, (01)04547410297546(11)210801(21)16824050, (01)04547410297546(11)210801(21)16824051, (01)04547410297546(11)210801(21)16824052, (01)04547410297546(11)210801(21)16824055, (01)04547410297546(11)210801(21)16824056, (01)04547410297546(11)211001(21)6623349, (01)04547410297546(11)220124(21)96722707, (01)04547410297546(11)220314(21)6123033, (01)04547410297546(11)220411(21)77221601, (01)04547410297546(11)220915(21)16323843, (01)04547410297546(11)230818(21)96522603, (01)04547410297546(11)230915(21)6123032, (01)04547410297546(11)231026(21)96722706, (01)04547410297546(11)231102(21)66120676, (01)04547410297546(11)231110(21)36725244, (01)04547410297546(11)231116(21)16623977, (01)04547410297546(11)231130(21)36825284, (01)04547410297546(11)231130(21)36825288, (01)04547410297546(11)231214(21)36825283, (01)04547410297546(11)231215(21)36825291, (01)04547410297546(11)231221(21)36725234, (01)04547410297546(11)240126(21)36725250, (01)04547410297546(11)240126(21)36925343, (01)04547410297546(11)240130(21)36925334, (01)04547410297546(11)240220(21)37025389, (01)04547410297546(11)240223(21)16623978, (01)04547410297546(11)240301(21)36925335, (01)04547410297546(11)240308(21)37025388, (01)04547410297546(11)240322(21)16623981, (01)04547410297546(11)240326(21)36725231, (01)04547410297546(11)240329(21)16623980, (01)04547410297546(11)240418(21)16824054, (01)04547410297546(11)240501(21)37125430, (01)04547410297546(11)240509(21)16623979, (01)04547410297546(11)240523(21)96622655, (01)04547410297546(11)240606(21)16824057, (01)04547410297546(11)240620(21)16623982, (01)04547410297546(11)240712(21)37125426, (01)04547410297546(11)240815(21)37125425, (01)04547410297546(11)240816(21)46525681, (01)04547410297546(11)240923(21)36825287, (01)04547410297546(11)240926(21)16623975, (01)04547410297546(11)241213(21)16323845, (01)04574102975456(11)17070176721324, (01)04574102975456(11)17070176721325; Serial No. 16223805, 16323842, 16323843, 16323844, 16323845, 16523949, 16523950, 16623962, 16623963, 16623964, 16623965, 16623966, 16623967, 16623968, 16623969, 16623970, 16623971, 16623972, 16623973, 16623974, 16623975, 16623975, 16623977, 16623977, 16623978, 16623978, 16623979, 16623980, 16623981, 16623981, 16623982, 16623982, 16724026, 16724027, 16724028, 16724031, 16724032, 16724033, 16724034, 16724035, 16824048, 16824049, 16824050, 16824051, 16824052, 16824054, 16824055, 16824056, 16824057, 16924082, 16924083, 17224248, 17224249, 26124301, 26224330, 26224331, 36725231, 36725231, 36725234, 36725239, 36725244, 36725250, 36825283, 36825284, 36825287, 36825288, 36825291, 36925334, 36925335, 36925343, 37025388, 37025389, 37125425, 37125426, 37125430, 46220029, 56920525, 57020577, 6123029, 6123031, 6123032, 6123033, 6123034, 6123035, 6123036, 6123037, 6123038, 6123039, 6123040, 6223076, 6223077, 6223078, 6223079, 6223080, 6223081, 6223082, 6223083, 6223084, 6223085, 6223086, 6223087, 6323188, 6323189, 6423194, 6423195, 6423196, 6423197, 6423198, 6423199, 6423200, 6423201, 6423202, 6523263, 6523264, 6523265, 6523266, 6523268, 6523269, 6523270, 66120669, 66120675, 66120676, 6623347, 6623348, 6623349, 6623350, 6623351, 6623352, 6623353, 66820905, 67121002, 67121004, 67121006, 67121008, 67121009, 76121055, 76121056, 76221098, 76221100, 76221108, 76321131, 76321132, 76321136, 76421207, 76421208, 76521235, 76521236, 76521237, 76521238, 76621277, 76621278, 76621287, 76721324, 76721325, 76821374, 76821375, 76821376, 77021484, 77021485, 77021486, 77121559, 77121560, 77121561, 77221600, 77221601, 77221602, 86121657, 86121658, 86121659, 86121660, 86221735, 86221736, 86221737, 86321784, 86421848, 86421849, 86421850, 86421851, 86521911, 86622007, 86622008, 87022243, 87022244, 87022245, 96422570, 96522599, 96522600, 96522601, 96522602, 96522603, 96622652, 96622653, 96622654, 96622655, 96722706, 96722707, 96822763, 96822764, 96822765, 96822766, 96822767, 96822768, 96822769, 96922826, 96922827, 96922828, 96922829, 96922830, 96922834, 97022856, 97022857, 97022858, 97022859, 97022860, 97022861, 97122920, 97122921, 97122922, 97122923, 97122924, 97122925, 97122926, 97122927, 97122928, 97122929, 97122930, 97122931, 97122932, 97222975, 97222976, 97222977, 97222978, 97222979, 97222980, 97222981, 97222982, 97222983, 97222984, 97222985, 97222986, 97222987, 97222988, 9922655, CLLE-0181, CLLE-0182, CLLE-0183, CLLE-0184, CLLE-0185, CLLE-0186, CLLE-0187, CLLE-0188, CLLE-0189, CLLE-0190, CLLE-0191, CLLE-0192, CLLE-0193, CLLE-0194, CLLE-0195, CLLE-0196, CLLE-0197, CLLE-0198, CLLE-0199, CLLE-0200, CLLE-0201, CLLE-0202, CLLE-0203, CLLE-0204, CLLE-0205, CLLE-0206, CLLE-0207, CLLE-0208, CLLE-0209, CLLE-0210, CLLE-0211, CLLE-0212, CLLE-0213, CLLE-0214, CLLE-0215, CLLE-0216, CLLE-0217, CLLE-0218, CLLE-0219, CLLE-0220, CLLE-0221, CLLE-0222, CLLE-0223, CLLE-0224, CLLE-0225, CLLE-0226, CLLE-0227, CLLE-0228, CLLE-0229.
- 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:
- FUJIFILM Healthcare Americas Corporation
- Reason for Recall:
- Devices had an unapproved slabbing software function enabled for use.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Product Codes/Lot Numbers:
Model No. CLLE-0229; UDI: (01)01547410297546(11)210701(21)16724035, (01)045474100297546(11)191001(21)967022860, (01)045474100297546(11)191001(21)97022857, (01)045474100297546(11)191001(21)97022858, (01)045474100297546(11)191001(21)97022861, (01)04547410294546(11)190801(21)96822763, (01)04547410294546(11)190801(21)96822764, (01)04547410294546(11)190801(21)96822765, (01)04547410294546(11)190801(21)96822767, (01)04547410294576(11)210501(21)16523949, (01)04547410294576(11)210501(21)16523950, (01)04547410294576(11)210601(21)16623962, (01)04547410294576(11)210601(21)16623963, (01)04547410297546(01)170601(21)76621287, (01)04547410297546(11)000100(21)67121008, (01)04547410297546(11)160107(21)66120675, (01)04547410297546(11)170201(21)76221098, (01)04547410297546(11)170220(21)67121004, (01)04547410297546(11)170301(21)76321131, (01)04547410297546(11)170301(21)76321132, (01)04547410297546(11)170301(21)76321136, (01)04547410297546(11)170501(21)76521235, (01)04547410297546(11)170501(21)76521236, 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(01)04547410297546(11)241213(21)16323845, (01)04574102975456(11)17070176721324, (01)04574102975456(11)17070176721325; Serial No. 16223805, 16323842, 16323843, 16323844, 16323845, 16523949, 16523950, 16623962, 16623963, 16623964, 16623965, 16623966, 16623967, 16623968, 16623969, 16623970, 16623971, 16623972, 16623973, 16623974, 16623975, 16623975, 16623977, 16623977, 16623978, 16623978, 16623979, 16623980, 16623981, 16623981, 16623982, 16623982, 16724026, 16724027, 16724028, 16724031, 16724032, 16724033, 16724034, 16724035, 16824048, 16824049, 16824050, 16824051, 16824052, 16824054, 16824055, 16824056, 16824057, 16924082, 16924083, 17224248, 17224249, 26124301, 26224330, 26224331, 36725231, 36725231, 36725234, 36725239, 36725244, 36725250, 36825283, 36825284, 36825287, 36825288, 36825291, 36925334, 36925335, 36925343, 37025388, 37025389, 37125425, 37125426, 37125430, 46220029, 56920525, 57020577, 6123029, 6123031, 6123032, 6123033, 6123034, 6123035, 6123036, 6123037, 6123038, 6123039, 6123040, 6223076, 6223077, 6223078, 6223079, 6223080, 6223081, 6223082, 6223083, 6223084, 6223085, 6223086, 6223087, 6323188, 6323189, 6423194, 6423195, 6423196, 6423197, 6423198, 6423199, 6423200, 6423201, 6423202, 6523263, 6523264, 6523265, 6523266, 6523268, 6523269, 6523270, 66120669, 66120675, 66120676, 6623347, 6623348, 6623349, 6623350, 6623351, 6623352, 6623353, 66820905, 67121002, 67121004, 67121006, 67121008, 67121009, 76121055, 76121056, 76221098, 76221100, 76221108, 76321131, 76321132, 76321136, 76421207, 76421208, 76521235, 76521236, 76521237, 76521238, 76621277, 76621278, 76621287, 76721324, 76721325, 76821374, 76821375, 76821376, 77021484, 77021485, 77021486, 77121559, 77121560, 77121561, 77221600, 77221601, 77221602, 86121657, 86121658, 86121659, 86121660, 86221735, 86221736, 86221737, 86321784, 86421848, 86421849, 86421850, 86421851, 86521911, 86622007, 86622008, 87022243, 87022244, 87022245, 96422570, 96522599, 96522600, 96522601, 96522602, 96522603, 96622652, 96622653, 96622654, 96622655, 96722706, 96722707, 96822763, 96822764, 96822765, 96822766, 96822767, 96822768, 96822769, 96922826, 96922827, 96922828, 96922829, 96922830, 96922834, 97022856, 97022857, 97022858, 97022859, 97022860, 97022861, 97122920, 97122921, 97122922, 97122923, 97122924, 97122925, 97122926, 97122927, 97122928, 97122929, 97122930, 97122931, 97122932, 97222975, 97222976, 97222977, 97222978, 97222979, 97222980, 97222981, 97222982, 97222983, 97222984, 97222985, 97222986, 97222987, 97222988, 9922655, CLLE-0181, CLLE-0182, CLLE-0183, CLLE-0184, CLLE-0185, CLLE-0186, CLLE-0187, CLLE-0188, CLLE-0189, CLLE-0190, CLLE-0191, CLLE-0192, CLLE-0193, CLLE-0194, CLLE-0195, CLLE-0196, CLLE-0197, CLLE-0198, CLLE-0199, CLLE-0200, CLLE-0201, CLLE-0202, CLLE-0203, CLLE-0204, CLLE-0205, CLLE-0206, CLLE-0207, CLLE-0208, CLLE-0209, CLLE-0210, CLLE-0211, CLLE-0212, CLLE-0213, CLLE-0214, CLLE-0215, CLLE-0216, CLLE-0217, CLLE-0218, CLLE-0219, CLLE-0220, CLLE-0221, CLLE-0222, CLLE-0223, CLLE-0224, CLLE-0225, CLLE-0226, CLLE-0227, CLLE-0228, CLLE-0229.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2219-2025
Related Recalls
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
FUJIFILM Healthcare Americas
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
FUJIFILM Healthcare Americas
The incorrect computed patient age is showing in VX for patients less than 3 months old.
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
FUJIFILM Healthcare Americas
When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.