ASPRIRE Cristalle Mammography System (cleared under… recallZ-2219-2025 · FUJIFILM Healthcare Americas Corporation · initiated Jun 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from FUJIFILM Healthcare Americas Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices had an unapproved slabbing software function enabled for use.
FDA root cause category: Process control
What the company is doing
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 [email protected]. Functional/upgrade questions can be directed to the Technical Assistance Center at 1-888-385-4622.
Recall details
- Recall number
- Z-2219-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 11, 2025
- Posted by the FDA
- Jul 30, 2025
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 293 units
- Product code
- OTE
- FDA submissions
- P160031
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
Product description
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Code information (models, lots, serial numbers)
Show the full code information (12k characters)
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, 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CLLE-0224, CLLE-0225, CLLE-0226, CLLE-0227, CLLE-0228, CLLE-0229.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ASPIRE Cristalle DR 3500 W 24X30 USA + EFujifilm Corporation · Full field digital,system,x-ray,mammographic1 recall5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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