Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammogra
Pending LLM rewrite. Source: FDA_DEVICE Z-0875-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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).
The recalled product
- Product
- Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- GTINs: 00840682118460
- 00840682142052
- 00840682145879
- 00195278022745
- 00195278276971
- 00195278661999
- 00195278665379
- 00195278914026
Distribution
Distribution scope not specified by the agency.
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