The Recall Desk
HighFDA (Devices)·Z-2161-2021·Announced 2021-08-04

OEC Elite Mobile C-Arm Recalled for Battery Depletion

GE OEC Medical Systems is recalling 3,570 OEC Elite mobile C-arm imaging systems worldwide due to potential early depletion of the battery that monitors X-ray tube temperature, which could render the system inoperable.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a potential early depletion of a battery monitoring X-ray tube temperature, which could render the system inoperable. This is a functional defect in a medical imaging device where injury has not yet been reported, meeting the criteria for High severity.

Plain-English summary

GE OEC Medical Systems is recalling 3,570 OEC Elite mobile C-arm systems. These devices are intended to provide fluoroscopic and digital spot images of patient anatomy, interventional tools and devices, and contrast agents during diagnostic, interventional, and surgical procedures.

The recalled systems were manufactured on or after January 2019 and distributed worldwide. The recall is due to a potential defect in the coin cell battery that monitors X-ray tube temperature.

The battery may deplete earlier than expected, which could cause the system to become inoperable.

The recalled product

Product
OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
Manufacturer
GE OEC Medical Systems, Inc
Category
Medical Device — Diagnostic Imaging
Hazard
  • battery-depletion
  • device-inoperability

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All OEC Elite systems manufactured on or after January 2019

Distribution

Distributed nationwide across the United States.

Related recalls

Same category