ProductGuru Recalls

Official recall record

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

US FDA — Medical Devices · 2023-10-09 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2023-10-09
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
00884838059450
Brand on record
Philips North America Llc

What the authority reported

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 to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

Other recalls from this brand

All 75 official recall notices naming Philips North America on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.