Device product
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Z-0168-2015
Product summary
- Event
- Event 69583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 124 units
- Official record key
device-enforcement:Z-0168-2015
Official wording
Reason: Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.
Code information: N/A
Distribution pattern: Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.
Derived failure modes
-
Device software or design
Error in the software