FDASeptember 9, 2021device

TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning

What to do

FDA enforcement status: Terminated

Brands named

raysearch laboratories abraysearchraysearch laboratories

UPCs

073500020100370735000201008207350002010075073500020102420735000201006807350002010112073500020101360735000201012907350002010204073500020102350735000201017407350002010266

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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