Health product recall

REVOLUTION CT (2021-10-11)

Starting date:
October 11, 2021
Posting date:
October 22, 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-76709

Last updated:
2021-10-22

Affected Products

A. REVOLUTION CT - MAIN UNIT
B. REVOLUTION CT ES
C. REVOLUTION APEX

Reason

There is a potential for the accumulated dose to be incorrectly displayed in certain situations. During an interventional exam using the Smartstep option, if the table height is adjusted after the exam starts, the Smartstep display will show a value that is higher than the actual dose delivered.

Affected products

A. REVOLUTION CT - MAIN UNIT

Lot or serial number

00000440051CN1
00000441839CN8
00000443342CN1
00000445060CN7
REVVX1600054CN
REVVX1700084CN
REVVX1900034CN
REVVX1900098CN

Model or catalog number

5590000
5590000-6

Companies
Manufacturer

GE Medical Systems LLC

3200 North Grandview Blvd

Waukesha

53188

UNITED STATES

B. REVOLUTION CT ES

Lot or serial number

REVV81900029CN
REVV81900035CN

Model or catalog number

5590000-15

Companies
Manufacturer

GE Medical Systems LLC

3200 North Grandview Blvd

Waukesha

53188

UNITED STATES

C. REVOLUTION APEX

Lot or serial number

REV2A2000017CN
REV2A2000029CN

Model or catalog number

840682146616

Companies
Manufacturer

GE Medical Systems LLC

3200 North Grandview Blvd

Waukesha

53188

UNITED STATES