Product Wiki · Recalls · Health Canada — Medical Devices

AIRO MOBILE CT SYSTEM (2021-09-19) — recall 62878

Health Canada — Medical Devices · Canada · 2021-10-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62878
Date of alert
2021-10-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/airo-mobile-ct-system-2021-09-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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