Product Wiki · Recalls · Health Canada — Medical Devices

Trexo Home and Trexo Plus — recall 74192

Health Canada — Medical Devices · Canada · 2023-08-24 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
74192
Date of alert
2023-08-24
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Physical medicine
Product type
Medical devices
Reported risk: The following malfunctions and nonconformances were observed during Trexo lab-testing and Trexo design reviews of the device, Resulting in this voluntary device recall and proposed field correction. Electromagnetic (EM) radiation levels above threshold (Ref: IEC 60601-1-11), as observed during lab-testing contracted by Trexo. Water ingress was observed within electronics enclosures after IP22 testing, as observed during lab-testing contracted by Trexo. Recall start date: July 31, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/trexo-home-and-trexo-plus

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