GE Medical Systems, LLC: Medical Device Recall in 2025 - (Recall #: Z-0875-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 24, 2025

Date Posted: December 17, 2025

Recall Number: Z-0875-2026

Event ID: 98081

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).

Status: Ongoing

Product Quantity: 1,818 (1,580 US; 238 OUS)

Code Information:

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

Distribution Pattern:

U.S. and OUS.

Voluntary or Mandated:

FDA Mandated