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Rainbow DCI Pulse CO-Oximeter Sensor (February 02, 2006)

Starting date:
February 02, 2006
Posting date:
August 07, 2006
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-31913

Reason

Sensors may not meet accuracy specifications due to tolerance of 1 of emitter's leds. May results in negative bias of 1% for oxygen (O2) and 4% for carbon monoxide(CO).

Affected products

Rainbow DCI Pulse CO-Oximeter Sensor

Lot or serial number

Serial numbers less than 6744

Model or catalog number

2051, 2052

Companies

Manufacturer
Not Applicable