Recall Z-0168-2015 ยท IYE Accelerator, Linear, Medical
Iba Dosimetry Gmbh
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
| Date | Nov 4, 2014 (initiated Sep 25, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on 09/25/2014. |
| Quantity | 124 units |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072374 | COMPASS Scanditronix Wellhofer GmbH, Dec 7, 2007 |