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