Product Wiki · Recalls · Health Canada — Medical Devices

AQURE SYSTEM — recall 55911

Health Canada — Medical Devices · Canada · 2016-08-23 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 55911
Date of alert: 2016-08-23
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: 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.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/aqure-system

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AQURE SYSTEM — recall 55911

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