This page has been archived on the Web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.
REVOLUTION CT - MAIN UNIT (2016-04-21)
- Starting date:
- April 21, 2016
- Posting date:
- May 16, 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, Hospitals, Healthcare Professionals
- Identification number:
- RA-58352
Affected products
- REVOLUTION CT - MAIN UNIT
Reason
GE Healthcare has become aware that an out of tolerance torque tool was used on three joints on revolution CT system during the manufacturing process. If the x-ray tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. There have been no injuries reported as a result of this issue.
Affected products
-
REVOLUTION CT - MAIN UNIT
Lot or serial number
- 443342CN1
Model or catalog number
- 5590000
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
Wisconsin
UNITED STATES