Health product recall

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