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Health product recall

AIRO Mobile CT Scanner (2017-09-26)

Starting date:
September 26, 2017
Posting date:
October 6, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Hospitals, Healthcare Professionals, General Public
Identification number:
RA-64788

Affected products

AIRO Mobile CT Scanner

Reason

Risk of unintended tilt motion of gantry while AIRO system is homing the axis at start up or preparing for a scan.

Affected products

AIRO Mobile CT Scanner

Lot or serial number

Firmware 1.0.6 to 1.0.7

Model or catalog number

MOBICT-32

Companies
Manufacturer
MOBIUS IMAGING, LLC
2 SHAKER ROAD
Shirley
01464
Massachusetts
UNITED STATES