Recall Z-0106-2016 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.
| Date | Oct 6, 2015 (initiated Aug 11, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 14 |
| Distribution | US Distribution to states of: MA, MO, OH, PA, UT, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142434 | ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 Siemens Medical Solutions USA, Inc., Nov 21, 2014 |