Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning GE Medical Systems Information Technologies, Inc. ComboLab System [Model or catalog number: 2300000-005; Lot or serial number: SVS23350013SA, SVS23460017SA, SVS23480016SA, SVS23480012SA, SVS23290001SA, SVS23330007SA, SVS23360008SA] [HKMD No.: 230058].
According to Health Canada, the manufacturer has become aware that capacitors in certain Prucka 3 Amplifiers used with Cardiolab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/combolab-system
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 May 2024