COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
This recall has been terminated (originally issued November 4, 2014).
- Recall Initiated
- September 25, 2014
- Posted
- November 4, 2014
- Terminated
- January 26, 2015
- Recall Number
- Z-0168-2015
- Quantity
- 124 units
- Official Source
- View on FDA website ↗
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
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.
Root Cause
Software design
Action Taken
The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on 09/25/2014.