Optima CT660 and Revolution EVO (2017-06-01)

Starting date:

June 1, 2017

Posting date:

January 12, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-65676

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  Reason
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  Affected products

Affected products

1. Optima CT660
2. Revolution EVO

Reason

GE Healthcare has recently become aware of a potential safety issue that can result in a scan starting before the prescribed delay has completed. More specifically, if an exam is interrupted during the prep delay period using the emergency stop button, and the scan is then resumed, the delay period may be shorter than expected. If personnel are in the scan room at the time of the premature scan initiation, they can be exposed to scatter X-Ray radiation.

Affected products