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AQURE SYSTEM
- Starting date:
- August 23, 2016
- 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-60042
Affected Products
AQURE SYSTEM
Reason
IN 2015, RADIOMETER BECAME AWARE THE AQURE SYSTEM HAS A DESIGN DEFECT REGARDING SAMPLE TYPE. IT IS CONSIDERED REMOTELY POSSIBLE THAT THE DESCRIBED ERROR BY THE AQURE/FLEXLINK SYSTEM WILL CAUSE A CRITICAL ADVERSE EVENT RESULTING IN SERIOUS INJURY INCLUDING AN INJURY THAT WOULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE IRREVERSIBLE IMPAIRMENT OR DAMAGE.
Affected products
AQURE SYSTEM
Lot or serial number
Version 2.1.1
Model or catalog number
933-599
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK