AIRO Mobile CT Scanner (2018-08-07)
- Starting date:
- August 7, 2018
- Posting date:
- August 17, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67458
Affected products
AIRO Mobile CT Scanner
Reason
The tube current modulation feature (modulated scans) is not working in AIRO Systems with software version 2.0.0.0 and operators would not be able to detect this fault until after a scan is completed.
Affected products
AIRO Mobile CT Scanner
Lot or serial number
Software version 2.0.0.0
Model or catalog number
MOBICT-32
Companies
- Manufacturer
-
MOBIUS IMAGING, LLC
2 SHAKER ROAD
Shirley
01464
Massachusetts
UNITED STATES