Big Bore RT with software version V4.8.0.10421 recall
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
Why was Big Bore RT with software version V4.8.0.10421 recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
- Recalling firm
- Philips North America Llc
- Quantity
- 56 units
- Distribution
- Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan
- Recall date
- November 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)