Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Reported: December 17, 2025 Initiated: October 24, 2025 #Z-0875-2026
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).
Details
- Recalling Firm
- GE Medical Systems, LLC
- Units Affected
- 1,818 (1,580 US; 238 OUS)
- Distribution
- U.S. and OUS.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography. Recalled by GE Medical Systems, LLC. Units affected: 1,818 (1,580 US; 238 OUS).
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 17, 2025. Severity: Moderate. Recall number: Z-0875-2026.
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