—#189039

Product

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

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K203443
Affected lot / code info: Serial Numbers: 176302 175681

Why it was recalled

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).

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2021-08-16
Posted by FDA: 2021-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189039. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.