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GE Medical Systems, LLC: Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

Medical DevicesSource: FDA (device) · Date: 2025-12-17

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
GE Medical Systems, LLC
Product
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Reason / hazard
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).
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. and OUS.
Recall initiated
2025-10-24
Code info
GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
Product quantity
1,818 (1,580 US; 238 OUS)
Voluntary mandated
FDA Mandated
City
Waukesha
State
WI
Country
United States
Event id
98081
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