GE Medical Systems, LLC: Device Recall

Recall #Z-0875-2026 · 10/24/2025

Class II: Risk

Recall Details

Recall Number: Z-0875-2026
Classification: Class II
Product Type: Device
Recalling Firm: GE Medical Systems, LLC
Status: Ongoing
Date Initiated: 10/24/2025
Location: Waukesha, WI, United States
Voluntary/Mandated: FDA Mandated
Product Quantity: 1,818 (1,580 US; 238 OUS)

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).

Product Description

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

Distribution Pattern

U.S. and OUS.

Other Recalls by GE Medical Systems, LLC

Class II: Risk 09/18/2025

The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Class II: Risk 09/18/2025

The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Class II: Risk 09/18/2025

The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Class II: Risk 08/22/2025

If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
Class II: Risk 07/02/2025

GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.

View all recalls by GE Medical Systems, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.