Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT Recalled by Philips North America Llc Due to For oncology users: If the user performed off-set...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips North America Llc directly.
Affected Products
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
Quantity: 56 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips North America Llc
Philips North America Llc has 301 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report