MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815
This recall is currently active, issued September 10, 2021. It was issued by Siemens Medical Solutions Usa, Inc.
- Recall Initiated
- August 16, 2021
- Posted
- September 10, 2021
- Recall Number
- Z-2447-2021
- Quantity
- 2 systems
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).
Distribution
US Nationwide distribution.
Lot / Code Info
Serial Numbers: 176302 175681
Root Cause
Software design
Action Taken
Siemens has initiated three (3) Customer Safety Advisory Notices (CSANs) to affected customers via SY052/21/S, CT042/21/S and MR019/21/S by email or hand delivery by the Siemens Customer Service Engineer on 8/16/21. Temporary workarounds are available for some of the software versions and are described in the CSANs. Additionally, a solution to eliminate the root cause of this problem is being distributed via SY051/21/S (for SY and CT) and MR021/21/S for MR to all affected customers free of charge. The service organization will contact you to arrange a date to perform this corrective action free of charge. Contact the service organization for an earlier appointment at 1-800-888-7436. ***UPDATE: 01/31/22 Additionally, a solution to eliminate the root cause of this problem is being distributed via CT049/21S, CT061/21/S, CT062/21/S, and CT088/21/S for CT. ***UPDATE: 03/12/22 Status Report Additional 13 S/N's added