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

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  Reason
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  Affected products

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