Product Wiki · Recalls · Health Canada — Medical Devices

BLOOD MONITORING UNIT 40 (BMU 40) (2020-09-22) — recall 61746

Health Canada — Medical Devices · Canada · 2020-10-16 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61746
Date of alert
2020-10-16
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The printed circuit board (PCBA Connector) of the BMU40 was designed with a short creepage distance. This PCBA Connector is positioned in the inner and backside of the metal enclosure of the BMU40. This may lead to shock, loss of data, or delay of use. Maquet Cardiopulmonary GmbH has not received any reports of serious injuries or death due to the malfunction of the PCBA Connector.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/blood-monitoring-unit-40-bmu-4

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