Recall Z-0875-2026
GE Medical Systems, LLC · initiated October 24, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Codes / lots: GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
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).
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
GE Healthcare notified sent customers notification letter dated October 24, 2025 and instructed in the letter, the customer will inspect and identify systems that have a missing or incorrect label.
Details
- Recall number
- Z-0875-2026
- Initiated
- October 24, 2025
- Posted by FDA
- December 9, 2025
- Product code
- MUE – Full Field Digital, System, X-Ray, Mammographic
- Quantity
- 1,818 (1,580 US; 238 OUS)
- Distribution
- U.S. and OUS.
- Recalling firm
- GE Medical Systems, LLC, Waukesha, WI