GE Senographe Pristina mammography systems recalled for missing or incorrect X-ray warning label
Some GE Senographe Pristina, Pristina Serena, and Pristina Serena 3D mammography systems were distributed with a missing or incorrect X-ray warning label. This label is required by federal regulation to inform users of radiation hazards. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All GE recalls
What to do
- Contact GE Medical Systems to verify your system's label is correct and complete
- Do not use the system if the X-ray warning label is missing or illegible until it is corrected
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 1,818 (1,580 US; 238 OUS)
- Illnesses reported
- None reported
- Manufactured in
- 3000 N Grandview Blvd, N/A, Waukesha, WI, United States
- Classification
- Class II
- Recall number
- Z-0875-2026
In the FDA's words
- Description
- Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography 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). GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026 Distribution: U.S. and OUS. Affected quantity: 1,818 (1,580 US; 238 OUS)
- Hazard
- 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).
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ModerateFDANov 4, 2026