REVOLUTION CT & APEX (2020-12-21)
- Starting date:
- December 21, 2020
- Posting date:
- January 7, 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-74701
Last updated:
2021-01-07
Affected Products
A. REVOLUTION CT - MAIN UNIT
B. REVOLUTION CT ES
C. REVOLUTION APEX
Reason
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
Affected products
A. REVOLUTION CT - MAIN UNIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5590000
5590000-6
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES
B. REVOLUTION CT ES
Lot or serial number
REVV81900002CN
REVV81900029CN
REVV81900035CN
Model or catalog number
5590000-15
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES
C. REVOLUTION APEX
Lot or serial number
REV2A2000017CN
REV2A2000029CN
Model or catalog number
840682146616
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES