CLASS II ONGOING Device recall · Reported 17 Dec 2025 · FDA Enforcement Report
Senographe Pristina, Pristina Serena, and Pristina Serena 3D recalled
GE Medical Systems is recalling Senographe Pristina, Pristina Serena, and Pristina Serena 3D. The recall was initiated on 24 Oct 2025 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-0875-2026
- FDA event ID
- 98081
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Oct 2025
- FDA classified
- 9 Dec 2025
- Reported
- 17 Dec 2025
- Type
- FDA Mandated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 24 Oct 2025 | Recall initiated by company | |
| 9 Dec 2025 | Classified by FDA | +46 days |
| 17 Dec 2025 | 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
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
Product as listed by the FDA
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Where it was distributed
U.S. and OUS.
Questions about this recall
Why was it recalled?
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
Which lots are affected?
GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
Where was it sold?
U.S. and OUS.
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.
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