This page has been archived on the Web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.

Health product recall

Optima X-Ray Systems (2013-12-05)

Starting date:
December 5, 2013
Posting date:
March 18, 2014
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-38245

Recalled Products

Optima  X-Ray Systems 

Reason

Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the mobile X-ray system are not properly displayed. If the user continues to attempt to select one of the exams when this issue has occurred, the system will update the screen and in doing so, potentially select a different exam/patient.

Affected products

A. Optima XR220AMX X-Ray

Lot or serial number

Not applicable

Model or catalog number

5555000-5
5555000-6

Companies
Manufacturer
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Alabama
UNITED STATES

B. Optima XR200AMX X-Ray System - Digital

Lot or serial number

Not applicable

Model or catalog number

5421698

Companies
Manufacturer
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Alabama
UNITED STATES