syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. This correction applies to customers who use the syngo RT
FDA device recall Z-0462-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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 recall call 925-602-8157.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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, B
- Date initiated
- 2011-11-02
- Date posted
- 2012-01-11
- Date terminated
- 2012-03-21
- 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 |
|---|---|---|
| ARTISTE SOLUTION WITH SYS_VB50 UPDATE (K103606) | Siemens Medical Solutions USA, Inc. | 2011-04-15 |