ASPIRE Cristalle (FDR MS-3500) Mammography machine recallZ-0386-2018 · Fujifilm Medical Systems U.S.A., Inc. · initiated Jul 14, 2017
Class II Terminated All recalls posted in January 2018
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 Medical Systems U.S.A., Inc. 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
There was a case that the swivel arm went down unintentionally when it was moved up/down.
FDA root cause category: Employee error
What the company is doing
FUJIFILM sent an Urgent: Medical Device Correction Letter dated July 14, 2017, accompanied by a Customer Feedback form to customers. PLEASE READ AND FOLLOW THE INSTRUCTIONS Please refer to the following page which provides the details of the problem and instructions for actions to be taken. Please follow the instructions in the ACTIONS TO BE TAKEN BY CUSTOMER/USER section. We sincerely regret the inconvenience that this may cause you. FUJIFILM is committed to providing products and services of the highest quality. Your satisfaction with FUJIFILM products and with our response to this issue is very important to us. If you have any questions about this matter, please contact your local FUJIFILM office. For further questions, please call (360) 356-6821.
Recall details
- Recall number
- Z-0386-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 14, 2017
- Posted by the FDA
- Jan 17, 2018
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 15 US 1 OUS
- Product code
- MUE
- FDA submissions
- K133972
- Distribution
- US Distribution and Internationally to Mexico.
Product description
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Code information (models, lots, serial numbers)
FDR MS-3500 : S/N- 76221095 or earlier
Other devices under the same FDA submission
2 devices cleared under K133972 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ASPIRE Cristalle DR 3500 W 24X30 USA + EFujifilm Corporation · Full field digital,system,x-ray,mammographic1 recall5 reports
- FDR-2000BPY POSITIONER KIT BPY-L HA USA EFujifilm Corporation · System, X-Ray, Mammographic2 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 18, 2026. Text above is shown as published by the FDA.
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