Z-0875-2026Class II

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

Name: Z-0875-2026 Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Creator: GE Medical Systems, LLC
Published: 2025-10-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2025-10-24 / Open, Classified / root cause: labeling and UDI

FDA source

GE Medical Systems, LLC began a recall of Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography on 2025-10-24. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0875-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-24
Posted: 2025-12-09
Recalling firm: GE Healthcare
Product: Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
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).
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare notified sent customers notification letter dated October 24, 2025 and instructed in the letter, the customer will inspect and identify systems that have a missing or incorrect label.
Quantity in commerce: 1,818 (1,580 US; 238 OUS)
Distribution: U.S. and OUS.
Product codes and lots: GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0875-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0875-2026	Class II	Ongoing	FDA Mandated	2025-12-17	2025-12-09

Product code MUE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)