Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
What to do
FDA enforcement status: Ongoing
Brands named
UPCs
Recall history
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