GE Medical Systems, LLC recalls Senographe Pristina
- Recalling company
- GE Medical Systems, LLC
- Product
- Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- Reason
- 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).
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 24, 2025
- Reported
- Dec 17, 2025
- Distribution
- U.S. and OUS.
- Status
- Ongoing
- Quantity
- 1,818 (1,580 US; 238 OUS)
- Lot / codes
- GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
- Company location
- Waukesha, WI
- Recall type
- FDA Mandated
- Recall number
- Z-0875-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0875-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.