CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report
Fujifilm Digital Mammography System Aspire HD recalled
Fujifilm Medical Systems U.S.A is recalling Fujifilm Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner, distributed in Hawaii, North Carolina. The recall was initiated on 9 Jun 2016 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-2690-2016
- FDA event ID
- 74525
- Recalling firm
- Fujifilm Medical Systems U.S.A, Stamford, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jun 2016
- FDA classified
- 30 Aug 2016
- Reported
- 7 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 9 Jun 2016 | Recall initiated by company | |
| 30 Aug 2016 | Classified by FDA | +82 days |
| 7 Sep 2016 | 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
If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
Product as listed by the FDA
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), 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
US Distribution to: NC and HI.
Questions about this recall
Is Fujifilm Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner recalled?
Yes. Fujifilm Medical Systems U.S.A recalled Fujifilm Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner on 9 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2690-2016.
Why was it recalled?
If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
Which lots are affected?
26330437 and 17230408
Where was it sold?
US Distribution to: NC and HI.
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 21 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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