FDAHealthOctober 24, 2025

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

⚠️ 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).

Is this relevant to me?

Geography: Unknown
Source agency: FDA
Category: Health
Published: October 24, 2025

U.S. and OUS.

What's affected?

Product: Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Brand: GE Medical Systems, LLC
Lot code: GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026

Additional details

GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026

What should I do?

Recommended action

Class II recall. FDA Mandated Quantity affected: 1,818 (1,580 US; 238 OUS).

View original FDA notice →

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