Product Wiki · Recalls · Health Canada — Medical Devices

Interface Modules (Circuit Board Failure) – Terumo Products — recall 49084

Health Canada — Medical Devices · Canada · 2012-09-03 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
49084
Date of alert
2012-09-03
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Terumo Cardiovascular Systems (Terumo CVS) has received ten reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities using the following modules for the Terumo Advanced Perfusion System 1: Serial interface module RS-232, Serial interface module RS-485, Interface module for CDI System 100/101, Interface module for CDI System 500. Some reports stated that the odour of smoke was associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. The investigation by Terumo CVS has determined that the malfunctions are caused by a circuit board that failed.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/interface-modules-circuit-boar

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