Product Wiki · Recalls · Health Canada — Medical Devices

SenTec Digital Monitor System - Monitor (2014-11-20) — recall 52902

Health Canada — Medical Devices · Canada · 2014-11-28 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
52902
Date of alert
2014-11-28
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: SenTec AG has become aware of the fact that one of its patient monitors, i.e. One SenTec Digital Monitor (REF SDM) has been distributed although one of the device's quality tests at the end of manufacturing was failed, namely the acceptance criterion for earth resistance (ground continuity test) was not met during electrical performance testing.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/sentec-digital-monitor-system-

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