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

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  Reason
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  Affected products

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