Health product recall

AQURE SYSTEM (2019-07-15)

Starting date:
July 15, 2019
Posting date:
August 2, 2019
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-70587



Last updated: 2019-08-02

Affected Products

AQURE SYSTEM

Reason

It was reported that during installation and validation of a third party device (TEG manager) connected to AQURE, wrong patient identification data was sent from AQURE. The data was not displayed on the device as it was rejected by the device. Thus, no patient mix-up occurred in the present case, however it could have happened.

Affected products

AQURE SYSTEM

Lot or serial number

2709959

2709965

2709975

2709978

2781290

2838054

All versions below 2.3.5

Model or catalog number

933-599

Companies
Manufacturer

Radiometer Medical Aps

Akandevej 21

Bronshoj

2700

DENMARK