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Compass System-Main Software Application (2014-09-25)
- Starting date:
- September 25, 2014
- Posting date:
- November 4, 2014
- 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-41979
Recalled Products
Compass System-Main Software Application
Reason
The reconstruction of the dose distribution in Compass 3.1 for Monaco-DMLC and Eclipse IMRT plans with jaw tracking enabled result in the same dose distribution as the dose computation, which has the potential of being erroneous. The reason for the wrong result is an error in the software that causes the reconstruction to be based only on the calculated fluence and not on the fluence derived from the measurement.
Affected products
Compass System-Main Software Application
Lot or serial number
VERSION COMPASS 3.1
Model or catalog number
CS10-100
Companies
- Manufacturer
-
IBA Dosimetry GmbH
Bahnhofstrasse 5
Schwarzenbruck
90592
GERMANY