The Recall Desk
HighFDA (Devices)·Z-2160-2021·Announced 2021-08-04

OEC 3D Imaging X-Ray Systems Recalled for Coin Cell Battery Depletion

GE OEC Medical Systems is recalling certain OEC 3D Imaging fluoroscopic X-ray systems due to potential premature depletion of the coin cell battery used to monitor X-ray tube temperature, which could cause the system to become 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: This FDA Class II device recall is classified as High because the OEC 3D Imaging system is a critical medical imaging device whose malfunction could disrupt diagnostic and surgical procedures. However, no reported illnesses, injuries, or deaths are documented in the source material, preventing a higher classification.

Plain-English summary

The affected product is the OEC 3D Imaging system, an image-intensified fluoroscopic X-ray system designed to provide diagnostic, interventional, and surgical imaging of adult and pediatric patients. A total of 3 units are subject to this recall.

The recall has been issued because the coin cell battery used to monitor X-ray tube temperature may deplete earlier than expected, causing the system to become inoperable during use.

The recalled units have been distributed worldwide, including to medical facilities throughout the United States and internationally in numerous countries including Canada, Germany, Japan, France, Australia, and others.

Users and healthcare providers who own or operate an OEC 3D Imaging system should contact GE OEC Medical Systems, Inc. for guidance regarding this recall. No illnesses or injuries have been reported in connection with this issue.

The recalled product

Product
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures
Manufacturer
GE OEC Medical Systems, Inc
Category
Medical Device — Diagnostic Imaging Equipment
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 3D Systems

Distribution

Distributed nationwide across the United States.

Related recalls

Same category