Electronic O2 Blender/Analyzer (2018-11-11)

Starting date:

November 11, 2018

Posting date:

November 28, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68442

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  Reason
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  Affected products

Affected products

Electronic O2 Blender/Analyzer

Reason

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.

Affected products