Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- Company
- Ge Medical Systems, Llc
- Recall Initiated
- October 24, 2025
- Posted
- December 9, 2025
- Recall Number
- Z-0875-2026
- Quantity
- 1,818 (1,580 US; 238 OUS)
- Firm Location
- Waukesha, WI
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).
Distribution
U.S. and OUS.
Lot / Code Info
GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
Root 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.
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