GE Medical Systems, LLC: Device Recall

Recall Details

Recall Number

Z-1819-2025

Classification

Class II

Product Type

Device

Recalling Firm

GE Medical Systems, LLC

Status

Ongoing

Date Initiated

03/21/2025

Location

Waukesha, WI, United States

Voluntary/Mandated

FDA Mandated

Product Quantity

Total for both products: 3472 (2,919 US; 553 OUS)

Reason for Recall

OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

Product Description

OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

Distribution Pattern

US and OUS

Other Recalls by GE Medical Systems, LLC

• Class II: Risk 10/24/2025
  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).
• 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.

View all recalls by GE Medical Systems, LLC →