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Recall Observatory FDA recall evidence

Device product

Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

Z-0875-2026

October 24, 2025

Class II

Product summary

Firm
GE Medical Systems, LLC
Event
Event 98081
Status
Ongoing
Classification
Class II
Quantity
1,818 (1,580 US; 238 OUS)
Official record key
device-enforcement:Z-0875-2026

Official wording

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 ¿1020.30(j).

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

Distribution pattern: U.S. and OUS.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).