Senographe Pristina recall
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Why was Senographe Pristina 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).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
- Product
- Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 1,818 (1,580 US; 238 OUS)
- Distribution
- U.S. and OUS.
- Recall date
- December 17, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)