Product Wiki · Recalls · Health Canada — Medical Devices

Electronic O2 Blender/Analyzer (2018-11-11) — recall 58876

Health Canada — Medical Devices · Canada · 2018-11-28 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
58876
Date of alert
2018-11-28
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: There is an intermittent failure that occurred with certain devices assembled with stepper motors that did not meet supplier specification. This causes a blender initialization fault upon start-up, or during an EPGS calibration attempt. System diagnostics recognizes this and posts an error message 'Gas System Knob Adjust Only' at which time the gas system flow and FiO2 control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/electronic-o2-blenderanalyzer-

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