Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Summary
The FDA issued a Class II for Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and by GE Medical Systems, LLC. Reason: Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.3.
Details
Source
Device Recall
External ID
Z-0875-2026
Action Date
2025-12-17
Status
Ongoing
Category
device
Product Description
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Lot/Code Info: GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
Quantity Affected: 1,818 (1,580 US; 238 OUS)
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.
Type: FDA Mandated
Recall Initiated: 2025-10-24
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, LLC have FDA actions?
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0875-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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