Health product recall

GE OEC ELITE (2021-06-21)

Starting date:
June 21, 2021
Posting date:
June 30, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75941

Last updated:
2021-06-30

Affected Products 

GE OEC ELITE

Reason

In certain OEC Elite and OEC 3D mobile C-Arms, when the voltage of the coin cell battery, which is used to monitor X-Ray tube temperature, is depleted, the system produces an error message and prevents further operation of the system. This may result in a delay or interruption of care.

Affected products

GE OEC ELITE

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

OEC ELITE

Companies
Manufacturer

GE OEC Medical Systems Inc.

384 Wright Brothers Drive

Salt Lake City

84116

Utah

UNITED STATES