Product Wiki · Recalls · Health Canada — Medical Devices

2nd Generation CentriMag™ Primary Console With Em-Tec Adult Flow Probe — recall 75670

Health Canada — Medical Devices · Canada · 2024-06-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
75670
Date of alert
2024-06-14
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: Abbott is notifying users of a potential issue identified through our internal process with the CentriMag™ console (2nd generation CentriMag™ primary console) which is a part of the CentriMag™ Circulatory Support System. Internal testing showed that due to a component change, the CentriMag™ console may not conform to the IEC 61000-4-5 standard. If subjected to a power surge above 1.8kV and up to 2.0 kV, the CentriMag™ console may shut down completely without alarm. A power surge may be caused by, including, but not limited to the following: lightning strike, unregulated power switching, or faulty equipment. Pumping would cease and the patient would have to be switched to a backup. Recall start date: May 22, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/2nd-generation-centrimagtm-pri

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