—#203847

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K171850
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan

Timeline

Recall initiated: 2023-10-09
Posted by FDA: 2023-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203847. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.