Big Bore RT with software version V4.8.0.10421- Model:… recallZ-0292-2024 · Philips North America Llc · initiated Oct 9, 2023

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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).

Recall details

Recall number

Z-0292-2024

Status

Open, Classified

Initiated by the company

Oct 9, 2023

Posted by the FDA

Nov 14, 2023

Recalling firm

Philips North America Llc

Quantity

56 units

Product code

JAK

FDA submissions

K171850

Distribution

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

Product description

Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Big Bore RT

  Philips Medical Systems Nederland B.V. · System, x-ray, tomography, computed
  4 recalls1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 93291).

• Z-0293-2024 · Open, Classified
  Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
• Z-0294-2024 · Open, Classified
  Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.