Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and… Recall
Issued November 22, 2023 · Philips North America Llc
In November 2023, Philips North America Llc recalled the Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Philips North America Llc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Philips North America Llc
- Category
- Health
- Recall date
- November 22, 2023
- Units affected
- Not reported
- Sold at
- Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore
- Recall number
- FDA-Z-0293-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Philips North America Llc has 34 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.