Z-0294-2024Class II

Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator...

Name: Z-0294-2024 Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator...
Creator: Philips North America Llc
Published: 2023-10-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-10-09 / Open, Classified

FDA source

Philips North America Llc began a recall of Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy on 2023-10-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0294-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-09
Posted: 2023-11-14
Recalling firm: Philips North America LLC
Product: Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
Product code: JAK System, X-Ray, Tomography, Computed
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.
FDA root cause: Under Investigation by firm
Action: Philips issued URGENT Medical Device Correction letter (UMDC) 2023-PD-CTAMI-015) dated 10/9/23. Letter states reason for recall, health risk and action to take: Below are short-term precautions to take until the permanent solution is installed. Enable the Force X/Y to 0/0 option on your device (Refer to the Instructions For Use, Section 3 Preparing for an Exam under Preferences, as well as Section 5 Summary of Scanning Workflows under Scan Workflow). Enabling this option will avoid the issue. After enabling the above referenced option, you may continue to use your system(s) in accordance with the intended use. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the software update (FCO 72800806) to resolve the issue. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 29 units
Distribution: Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0294-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0292-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-14
Z-0293-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-14
Z-0294-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-14

Product code JAK

K171850Class IIPhilips CT Big BorePhilips Medical Systems (Cleveland), Inc. / cleared 2017-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)