CT Scanner Image Fusion Software Error Affecting Radiation Therapy Planning
A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The issue describes a risk-of-harm scenario where incorrect radiation therapy planning could result in serious patient outcomes. Per the severity rubric, this qualifies as High (Score 3) for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips is recalling 29 units of the Brilliance CT Big Bore Oncology scanner (Model 728243, software version V4.8.0.10421) used for radiation oncology planning and simulation. The device is distributed nationwide and internationally.
When users perform off-set image reconstruction, the image fusion feature can display a shift in the contouring area, causing incorrect coordinates to be sent to the treatment planning system. This may result in incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen.
For radiology users, off-set reconstruction after multiple acquisitions can cause inaccurate relative positioning, potentially leading to incorrect diagnosis and treatment.
The recalled product
- Product
- Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
- Manufacturer
- Philips North America Llc
- Affected units
- 29
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
- HighPhilips Recalls Brilliance Big Bore Oncology CT Scanners Due to Software Errors
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