Product Wiki · Recalls · Health Canada — Medical Devices

MyLabAlpha - MyLabGamma - MyLabDelta (2020-09-30) — recall 62355

Health Canada — Medical Devices · Canada · 2021-04-22 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62355
Date of alert
2021-04-22
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Performing a technical investigation related to a complaint reported from the USA market, Esaote received notice by the manufacturer of the AC/DC adapter (manufacturer XP Power, model AHM180PS19) of the portable ultrasound system MyLabAlpha that, due to the design of the PCB, an unlikely mechanical failure may reduce the system protection against electric shock hazard. This condition can be caused by the mechanical stress of the connection between the AC/DC power adapter and the mains cable over the time of use.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/mylabalpha-mylabgamma-mylabdel

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