Z-2447-2021Class II

MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key...

Name: Z-2447-2021 MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key...
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-08-16
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-08-16 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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 on 2021-08-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2447-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-16
Posted: 2021-09-10
Recalling firm: Siemens Medical Solutions USA, Inc.
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
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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).
Root cause tag: software
FDA root cause: Software design
Action: 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
Quantity in commerce: 2 systems
Distribution: US Nationwide distribution.
Product codes and lots: Serial Numbers: 176302 175681

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2447-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2445-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-10
Z-2446-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-10
Z-2447-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-10

Product code LNH

K203443Class IIMAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc. / cleared 2021-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)