CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
Asprire Cristalle Mammography System recalled
Fujifilm Healthcare Americas is recalling Asprire Cristalle Mammography System (cleared under K212873) installed with the Aspire, distributed nationwide in the US. The recall was initiated on 11 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2219-2025
- FDA event ID
- 97063
- Recalling firm
- Fujifilm Healthcare Americas, Lexington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jun 2025
- FDA classified
- 30 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 11 Jun 2025 | Recall initiated by company | |
| 30 Jul 2025 | Classified by FDA | +49 days |
| 6 Aug 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices had an unapproved slabbing software function enabled for use.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
Questions about this recall
Why was it recalled?
Devices had an unapproved slabbing software function enabled for use.
Which lots are affected?
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)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, 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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, 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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.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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