Radiation therapy system - Syngo Based WS for 3rd party V&R equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.
FDA device recall Z-2100-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Distribution
- Class II Recall - Product distribution information pending from firm.
- Date initiated
- 2008-05-15
- Date posted
- 2008-09-17
- Date terminated
- 2010-12-20
- Location
- Concord, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |