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