Recall Details
- Start Date
- 2021-10-11
- Categories
- Health Products
Summary
Issue: Medical Devices
Audience: General Public, Healthcare Professionals, Hospitals
Category: Medical Device
Alert type: Medical Device Recall
Department: Health Canada
Hazard classification: Type II
Introduction
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.
A. REVOLUTION CT - MAIN UNIT
Brand name: 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
Brand name: 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
Brand name: 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
Identification number
Identification number: RA-76709