PlainRecalls
FDA Devices Moderate Class II Ongoing

Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.

Reported: November 22, 2023 Initiated: October 9, 2023 #Z-0293-2024

Product Description

Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.

Reason for Recall

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.

Details

Recalling Firm
Philips North America Llc
Units Affected
11 units
Distribution
Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled? ▼
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.. Recalled by Philips North America Llc. Units affected: 11 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 22, 2023. Severity: Moderate. Recall number: Z-0293-2024.

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