Product Wiki · Recalls · Health Canada — Medical Devices

Automated Field Steam Sterilizer (2021-08-19) — recall 62879

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

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Agency
Health Canada — Medical Devices
Recall identifier
62879
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: FDI has determined through internal testing on august 11th 2021, that the rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground. To be fully compliant with the electrical standard ul 61010-1 2nd edition, section 6.5.2.4, All metal components accessible by the user must have an impedance to ground of 0.1 Ohms or less. In the unlikely event of a damaged or faulty wire within the rear heater assembly, the rear heater plate and cover assembly could potentially become energized.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/automated-field-steam-steriliz

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