Device product
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Z-1212-2015
Product summary
- Event
- Event 70545
- Status
- Terminated
- Classification
- Class II
- Quantity
- 124 units
- Official record key
device-enforcement:Z-1212-2015
Official wording
Reason: Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
Code information: Model : SW Version 3.1 Lot or Serial Number : n.a
Distribution pattern: Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam.
Derived failure modes
-
Device software or design
Error in the software