Health product recall

AIRO MOBILE CT SYSTEM (2021-09-19)

Starting date:
September 19, 2021
Posting date:
October 1, 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-76561

Last updated:
2021-10-01

Affected Products

AIRO MOBILE CT SYSTEM

Reason

Stryker has determined through internal investigation (during testing at the production level) that a fuse block located within the system requires additional insulation to ensure the airo truct complies with applicable electronic requirements for medical devices (iec 60601-1).

Affected products

AIRO MOBILE CT SYSTEM

Lot or serial number

All lots.

Model or catalog number

MOBICT-32

Companies
Manufacturer

MOBIUS IMAGING, LLC

2 SHAKER ROAD

Shirley

01464

Massachusetts

UNITED STATES