medical Class II Updated 2023-11-22

Philips North America Llc recalls Big Bore RT with software version V4.8.0.10421- Model: 72824

Recalled Product

Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: (01)00884838095168 Serial Numbers; Serial Number 20094 20078 766037 20064 20051 20063 766015 766013 20053 20052 20039 766003 763011 20033 763006 20023 763004 20092 766075 768020 20093 766073 766074 766072 766071 766070 766069 766068 766065 766067 766066 766064 766061 766062 766063 766060 766059 766058 763030 766057 20086 20090 763033 763032 766080 763031 766081 766079 766078 20091 766076 766077 763010 763018 20040 766047
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