MR MAGNETOM Systems with RT Image Suite with syngo MR… recallZ-2447-2021 · Siemens Medical Solutions USA, Inc · initiated Aug 16, 2021
Class II Open, Classified All recalls posted in September 2021
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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).
FDA root cause category: Software design
What the company is doing
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
Recall details
- Recall number
- Z-2447-2021
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Aug 16, 2021
- Posted by the FDA
- Sep 10, 2021
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 2 systems
- Product code
- LNH
- FDA submissions
- K203443
- Distribution
- US Nationwide distribution.
Product description
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
Code information (models, lots, serial numbers)
Serial Numbers: 176302 175681
Other devices under the same FDA submission
1 device cleared under K203443 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MAGNETOM Vida 11516152Siemens Healthcare GmbH · System, nuclear magnetic resonance spectroscopic1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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