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U.S. Department of Health and Human Services

Class 2 Device Recall Senographe Pristina, Pristina Serena, and Pristina Serena 3D

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 Class 2 Device Recall Senographe Pristina, Pristina Serena, and Pristina Serena 3Dsee related information
Date Initiated by FirmOctober 24, 2025
Date PostedDecember 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0875-2026
Recall Event ID 98081
510(K)NumberK162268 K173576 K182951 
Product Classification Full field digital, system, x-ray, mammographic - Product Code MUE
ProductSenographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Code Information GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
FEI Number 2126677
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3011
Manufacturer 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 2		Radiation Control for Health and Safety Act
ActionGE 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.
Quantity in Commerce1,818 (1,580 US; 238 OUS)
DistributionU.S. and OUS.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MUE
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