Recall Z-0462-2012 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. This correction applies to customers who use the syngo RT Therapist v4.2 or the combination of syngo RT Therapist v4.2 with syngo RT Oncologist v4.2 from Siemens. 12/7/2011: Update: Syngo RTT4.2.108 SW contains the same SW content when installed on the syngo Oncologist Workspace (license key controlled). Currently the syngo Oncologist S
| Date | Jan 11, 2012 (initiated Nov 2, 2011) |
| Status | Terminated |
| Reason | The software release will bring current Installed Base system to the forward production version. It is a result of the final system testing addressing several safety issues that are not critical for the safe use of the device and multiple performance defects. |
| Root cause | Software design |
| Action | Siemens sent Customer Information letters and Update Instructions TH024/11/S for the installation of software release 4.2.108 beginning on November 2, 2011 to all affected consignees. Sites with active devices for the Oncology system were sent the current Update Instructions TH014/11/S for the installation of software release 4.2.108 and Customer Information letter beginning November 22, 2011. Consignees were asked to include the Customer Information in their syngo RT Oncologist System Owner Manual chapter "Safety Advisory Letters" where it should remain. For questions regarding this reca |
| Quantity | 85 affected customers RT Therapa[ist, 62 customers Oncology |
| Distribution | Worlwide Distribution - USA (nationwide) including UT, OH, TN, FL, WI, IN, KY, CA, PA, SD, NY and the countries of India, Germany, United Kingdom, Australia, Poland, Japan, Croatia, India, Columbia, Belgium, Puerto Rico, China, Sweden, South Africa and Czech Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103606 | ARTISTE SOLUTION WITH SYS_VB50 UPDATE Siemens Medical Solutions USA, Inc., Apr 15, 2011 |