Recall Z-2104-2008 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Radiation therapy system - PRIMEVIEW 3i System 2.1 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147675. Medical charged particle Radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.
| Date | Sep 17, 2008 (initiated May 15, 2008) |
| Status | Terminated |
| Reason | Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage. |
| Root cause | Software design |
| Action | An Urgent Medical Device Correction - Customer Safety Advisory Notice letter (TH014/08/S) was released on May 15, 2008. A new software patch is under construction and is planned for release in June 2008. If you have any questions contact Roland Betz at (925) 246-8407. |
| Distribution | Class II Recall - Product distribution information pending from firm. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060226 | ONCOR EXPRESSION Siemens Medical Solutions USA, Inc., Mar 15, 2006 |