Philips recalls Brilliance CT Big Bore scanners with software version V4.8.0.10421 (model 728244) due to potential incorrect radiation therapy planning causing cancer growth. Affected units may require software update.
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.
Take action
Contact the company
📍Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289
✎ GovInfoNow plain-language explainer
Philips is recalling certain Brilliance CT Big Bore scanners with software version V4.8.0.10421 that could cause incorrect radiation therapy planning. This might lead to cancer growth or spread if treatment is not properly adjusted. The recall affects medical facilities using these scanners for oncology and radiology. Read more at govinfonow.com/recall/57118-philips-brilliance-ct-big-bore-software-v4-8-0-10421.
“Philips Brilliance CT Big Bore Software V4.8.0.10421 Recall: Incorrect Radiation Therapy.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57118-philips-brilliance-ct-big-bore-software-v4-8-0-10421. Based on FDA recall #Z-0293-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0293-2024%22&limit=1).
The FDA announced on Oct. 9, 2023, that Philips North America LLC is recalling Brilliance CT Big Bore CT scanners and simulators due to potential incorrect radiation therapy planning or diagnosis. The agency issued recall number Z-0293-2024 for the voluntary Class II action.
How to tell if you have it
Brand: Philips
Product: Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation
For oncology users, off-set reconstruction may cause shifts in contouring areas or incorrect coordinates during image fusion, potentially leading to incorrect radiation therapy planning and cancer growth. For radiology users, multiple acquisitions may result in inaccurate Relate Position, which could lead to incorrect diagnosis and treatment.
Context
GovInfoNow's records show Philips North America LLC has 129 other recalls on record since July 12, 2017. Recent Philips recalls include the Aug. 21, 2026, Achieva 3.0T MRI recall for software issues terminating scans and the Aug. 18, 2026, Spectral CT 7500 Scanner recall for potential extra radiation exposure. Other recent recalls of similar products include the June 11, 2026, IQon Spectral CT Upgrades (risk of inadequate scans), the June 26, 2026, Incisive CT Software V4.5/V5.0 Recall (potential bolus tracking failure), and the June 11, 2026, Ingenuity CT Scanners recall (manual trigger need).
How to tell if you have this one
Check if your scanner has software version V4.8.0.10421 and model number 728244. The serial numbers listed in the recall include 760012, 7742, 75043, and other specific numbers.
Brand
Philips
Product
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan
Recall number
Product, codes & lots
Quantity
Z-0292-2024
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.; UDI-DI: (01)00884838095168 Serial Numbers; Serial Number 20094 20078 766037 20064 20051 20063 766015 766013 20053 20052 20039 766003 763011 20033 763006 20023 763004 20092 766075 768020 20093 766073 766074 766072 766071 766070 766069 766068 766065 766067 766066 766064 766061 766062 766063 766060 766059 766058 763030 766057 20086 20090 763033 763032 766080 763031 766081 766079 766078 20091 766076 766077 763010 763018 20040 766047
56 units
Z-0293-2024
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.; UDI-DI: (01)00884838059450 Serial Numbers: 760012 7742 75043 76137 76005 7830 76202 76134 76038 7871 7825
11 units
Z-0294-2024
Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.; UDI-DI: (01)00884838059450 Serial Numbers: Serial Number 7362 75114 7441 7449 7996 7104 7333 7991 7497 7762 7254 7373 7674 7783 7971 7802 7385 7840 7353 750010 75107 8007 7990 7716 7689 7618 75045 7442 750017
29 units
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your scanner's software version is V4.8.0.10421 and model number 728244.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0293-2024 (October 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0293-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.