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Recall Observatory FDA recall evidence

Device 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

Z-2447-2021

August 16, 2021

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 88588
Status
Ongoing
Classification
Class II
Quantity
2 systems
Official record key
device-enforcement:Z-2447-2021

Official wording

Reason: 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).

Code information: Serial Numbers: 176302 175681

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).