This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT (2015-12-23)
- Starting date:
- December 23, 2015
- Posting date:
- January 14, 2016
- 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-56646
Affected Products
A. OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
Reason
GE Healthcare has recently become aware of an issue related to the operation of the safety latch within the column that supports the horizontal arm. This safety latch mechanism serves as a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person. There have been no incidents or injuries reported as a result of this internally found issue.
Affected products
A. OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5416437GTC
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
Wisconsin
UNITED STATES