FDA-Device2021-09-22Class II

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

Siemens Medical Solutions USA, Inc
Hazard

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).

Sold states
US Nationwide distribution.
Affected count
2 systems
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2447-2021

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