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Artiste MV System - Digital Linear Accelerator (2014-06-12)
- Starting date:
- June 12, 2014
- Posting date:
- July 3, 2014
- 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-40367
Recalled Product
Artiste MV System - Digital Linear Accelerator
Reason
Siemens became aware of an error in the pressure/temperature compensation for dose monitor 2 for electron treatments. Only Digital Linear Accelerators (Linac) running control console software version 12 or 13 are affected. This error may result in a higher deviation of the dose rate in electron mode than specified. The dose monitor 1 controls the overall dose monitoring system and remains unaffected. The actual dose rate and the accumulated monitor units and thus the absolute dose are correctly displayed at the linac console.
Affected products
Artiste MV System - Digital Linear Accelerator
Lot or serial number
5414
Model or catalog number
8139789
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY