Z-0875-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2025
- Initiation Date
- October 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 1,818 (1,580 US; 238 OUS)
Product Description
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
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 Pattern
U.S. and OUS.
Code Information
GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026