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AQUARIUS Workstation Basic Unit (2015-01-21)
- Starting date:
- January 21, 2015
- Posting date:
- March 5, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-52449
Recalled Products
AQUARIUS Workstation Basic Unit
Reason
Software anomaly related to the Recist 1.1 target lesion evaluation criteria in the findings workflow module within the aquarius workstation intuition client viewer. In certain instances, this target lesion evaluation output provided by the software may be inaccurate. The total measurement calculation and percentage of change are accurate. The affected versions are 4.4.11.82.6784, 4.4.11.116.7134 and 4.4.11.144.7589.
Affected products
AQUARIUS Workstation Basic Unit
Lot or serial number
AQ-UH4940
AQ-UH7915
AQ-UH8040
AQ-UH8486
Model or catalog number
84-0069
Companies
- Manufacturer
-
TeraRecon, Inc.
4000 East 3rd Avenue Suite 200
Foster City
94404
California
UNITED STATES