Fujifilm Mammography Suite Recall: Duplicate Image ID Risk
Fujifilm recalls mammography software that may assign duplicate image IDs, causing overwritten images in PACS systems. Affected units include specific software versions of the FCRMS system.
Lower-risk recall
FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
Contact the company
What happened, in plain English
Fujifilm is recalling its Computed Radiography Mammography Suite software that may assign duplicate image IDs. This could cause images to be overwritten in hospital PACS systems, potentially leading to missed diagnoses. Read more at govinfonow.com/recall/73245-fujifilm-mammography-suite-recall-duplicate-image-id-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73245-fujifilm-mammography-suite-recall-duplicate-image-id-risk · Updated September 19, 2026 · FDA enforcement record: FDA #Z-0662-2018
Cite this page
“Fujifilm Mammography Suite Recall: Duplicate Image ID Risk.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73245-fujifilm-mammography-suite-recall-duplicate-image-id-risk. Based on FDA recall #Z-0662-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0662-2018%22&limit=1).
Why it’s dangerous
The system may assign the same unique ID number to new and previous image sets due to a software error. If this happens, the new images could overwrite older images in the hospital's PACS system, potentially causing missed diagnoses.
Who’s affected
Healthcare facilities using the Fuji Computed Radiography Mammography Suite with specific software versions (V5.1, V6.0) are affected. Patients receiving mammograms through these systems may be at risk of incorrect images being stored.
How to tell if you have this one
Check if your mammography system uses the Fuji Computed Radiography Mammography Suite (FCRMS) with software versions V5.1 or V6.0. The affected models include CR-IR363AWS.
- Brand
Fujifilm Medical Systems- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution.
| Recall number | Product, codes & lots |
|---|---|
| Z-0659-2018 | Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.; 1000AWS. Released Software Versions: V5.0, V5.1. Not Released Software Versions: V5.2, V6.0, V6.1, V7.0. |
| Z-0660-2018 | Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-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.; 2000AWS. Released Software Versions: V5.1, V6.0, V6.1. Not Released Software Versions: V5.0, V5.2, V7.0. |
| Z-0661-2018 | ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.; 3000AWS. Released Software Versions: V5.1, V5.2, V6.0, V6.1, V7.0. Not Released Software Versions: V5.0. |
| Z-0662-2018 | Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.; 363AWS. Released Software Versions: V5.1, V6.0. Not Released Software Versions: V5.0, V5.2, V6.1, V7.0. |
What to do — step by step
Check Software Version
Verify your system's software version is V5.1 or V6.0 to determine if it is affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0662-2018 (August 4, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0662-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.