Recall archive / FDA device enforcement
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomos... — FDA record Z-2219-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
- Reason
- Devices had an unapproved slabbing software function enabled for use.
- Classification
- Class II
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 293 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2219-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, (01)04547410297546(11)170501(21)76521237, (01)04547410297546(11)170501(21)76521238, (01)04547410297546(11)170720(21)76621277, (01)04547410297546(11)170731(21)76621278, (01)04547410297546(11)170801(21)76821374, (01)04547410297546(11)170801(21)76821375, (01)04547410297546(11)170923(21)76121056, (01)04547410297546(11)171001(21)77021484, (01)04547410297546(11)171001(21)77021485, (01)04547410297546(11)171001(21)77021486, (01)04547410297546(11)171006(21)76821376, (01)04547410297546(11)171101(77)121559, (01)04547410297546(11)171101(77)121560, (01)04547410297546(11)171101(77)121561, (01)04547410297546(11)180101(01)86121657, (01)04547410297546(11)180101(86)121658, (01)04547410297546(11)180101(86)121659, (01)04547410297546(11)180101(86)121660, (01)04547410297546(11)180423(21)76421207, (01)04547410297546(11)180502(21)86321784, (01)04547410297546(11)180518(21)76421208, (01)04547410297546(11)181026(21)86421848, (01)04547410297546(11)190103(21)77221602, (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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 6, 2025
- Recall initiation date
- Jun 11, 2025
- Center classification date
- Jul 30, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.