CLASS II Device recall · Reported 28 Feb 2018 · FDA Enforcement Report
Aspire Cristalle (for Fdr-3000AWS) The Fujifilm Digital recalled
Fujifilm Medical Systems U is recalling Aspire Cristalle (for Fdr-3000AWS) The Fujifilm Digital Mammography System, Aspire. The recall was initiated on 4 Aug 2017 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-0661-2018
- FDA event ID
- 79078
- Recalling firm
- Fujifilm Medical Systems U, Stamford, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Aug 2017
- FDA classified
- 20 Feb 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 4 Aug 2017 | Recall initiated by company | |
| 20 Feb 2018 | Classified by FDA | +200 days |
| 28 Feb 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
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
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.
Where it was distributed
Worldwide Distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
3000AWS. Released Software Versions: V5.1, V5.2, V6.0, V6.1, V7.0. Not Released Software Versions: V5.0.
Where was it sold?
Worldwide Distribution.
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.
Other products in this recall event
3 other products · FDA event 79078This product is part of a recall event; the main page for the event is Fuji Computed Radiography Mammography Suite, Fcrms recalled.
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|---|---|---|---|---|---|
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