Product Wiki · Recalls · Health Canada — Medical Devices

ComboLab System — recall 58292

Health Canada — Medical Devices · Canada · 2018-07-27 · Type II

As described by Health Canada — Medical Devices: ComboLab System - Main Unit, CardioLab System - Main Unit, Mac-Lab System - Main Unit, and Mac-Lab Systems - Integrated Electronics Box (2018-06-14)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
58292
Date of alert
2018-07-27
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The following issue is being addressed by GE healthcare file no. FMI 12269: GE Healthcare has recently become aware that the system side of the power cord may break and expose the electrical conductors leading to the risk of shock. This can lead to injuries up to and including cardiac arrhythmia or cardiac arrest.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/combolab-system-main-unit-card

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