ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
This recall is currently active, issued July 30, 2025. It was issued by Fujifilm Healthcare Americas Corporation.
- Recall Initiated
- June 11, 2025
- Posted
- July 30, 2025
- Recall Number
- Z-2219-2025
- Quantity
- 293 units
- Firm Location
- Lexington, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Devices had an unapproved slabbing software function enabled for use.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
Lot / Code Info
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)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.
Root Cause
Process control
Action Taken
An URGENT: MEDICAL DEVICE RECALL FIRST NOTICE, dated 6/10/25, was sent to consignees. Consignees are to post the notification on/near affected devices and return the completed response form to coordinate a field service engineer to visit. Fujifilm will be sending a Fujifilm healthcare engineer to inspect affected systems and correct the settings to ensure the slabbing feature is inactive. Customers with any questions can contact Fujifilm Customer Service at 1-888-385-4633 or Fujifilm's Field Action Coordinator, Jay Wigley, at hcusquality@fujifilm.com. Functional/upgrade questions can be directed to the Technical Assistance Center at 1-888-385-4622.