Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmen
FDA device recall Z-0106-2016 · posted 2015-10-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. The safety-related issues, which were described in the Customer Safety Notice distributed as UFSN-RTT/RTO 4.3 Adaptive Targeting [Auto-registration]. The update contains several important safety and performance fixes.
- Action taken
- The firm, Siemens, sent Recall letters, dated August 2015, that describe the product, the problem, and correction, will be hand-delivered to affected sites at the time the fix is implemented by a Siemens technician. If you have any questions, contact Regulatory Technical Specialist at 610-448-6471 or email: marlynne.galloway@siemens.com
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 14
- Distribution
- US Distribution to states of: MA, MO, OH, PA, UT, and WI.
- Date initiated
- 2015-08-11
- Date posted
- 2015-10-06
- Date terminated
- 2016-12-07
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 (K142434) | Siemens Medical Solutions USA, Inc. | 2014-11-21 |