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

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

Electronic O2 Blender/Analyzer

Lot or serial number

contact manufacturer

Model or catalog number
  • 801188
Companies
Manufacturer
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES