Z-1212-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2015
- Initiation Date
- February 2, 2015
- Termination Date
- August 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124 units
Product Description
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Reason for Recall
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.
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.
Code Information
Model : SW Version 3.1 Lot or Serial Number : n.a