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Health product recall

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