Revolution CT (2018-10-17)
- Starting date:
- October 17, 2018
- Posting date:
- November 15, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68218
Affected products
Revolution CT
Reason
GE Healthcare has become aware of a localization error on revolution CT systems equipped with the smartstep option. The z location displayed on image annotation and on the gantry display may not be the actual location of the table. This can occur if:
- The table has been moved all the way out of the gantry using the 'out' button on the gantry control or the 'unload pedal'.
- The table is then moved back into the gantry using the 'move to start location' button on the hand held controller.
In this situation, if a scan is initiated by the user, the scan may be acquired in the wrong location. An additional scan may be necessary.
Affected products
Revolution CT
Lot or serial number
- 00000440051CN1
- 00000441839CN8
- 00000442219CN2
- 00000443342CN1
- REVVX1600054CN
- REVVX1700084CN
Model or catalog number
- 5590000
- 5590000-6
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES