FDA recall Z-1819-2025

GE Medical Systems, LLC · Class II · device

Product

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.

Reason for recall

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

Distribution

US and OUS

Key facts

Status
Ongoing
Initiation date
2025-03-21
Report date
2025-06-18
Voluntary/Mandated
FDA Mandated
Location
Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1819-2025