Philips Brilliance CT Big Bore May Send Incorrect Coordinates During Radiation Therapy Planning
Philips Brilliance CT Big Bore units with software V4.8.0.10421 may produce inaccurate image position data when offset reconstruction is used. This could lead to incorrect radiation therapy planning or diagnosis.
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 medical device recall with potential for serious harm. No reported illnesses or injuries have been confirmed in the source material. However, the software defect could lead to incorrect radiation therapy planning and diagnosis. This meets the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Brilliance CT Big Bore (Model 728244, software V4.8.0.10421) is a CT scanner and simulator designed for radiation oncology and therapy. Approximately 11 units have been identified as affected. The device is distributed nationwide and internationally.
A software issue occurs when users perform offset reconstruction on the CT device. For radiation oncology users, this can cause a shift in the contouring area of primary and secondary image sets when using image fusion in the treatment planning system (TPS). Incorrect coordinates may be sent to the TPS when using absolute patient marking, which could result in incorrect radiation therapy planning and potential growth or spread of cancer due to an incorrect early treatment regimen. For radiology users, the inaccurate position data after multiple acquisitions could lead to incorrect diagnosis and treatment.
Users should review their usage of offset reconstruction and verify treatment planning data. Consult with Philips or your institution's medical physics team for guidance on whether your device's serial number is affected and for recommended actions.
The recalled product
- Product
- Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
- Manufacturer
- Philips North America Llc
- Affected units
- 11
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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