Z-0168-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2014
- Initiation Date
- September 25, 2014
- Termination Date
- January 26, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124 units
Product Description
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Reason for Recall
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.
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.
Code Information
N/A