FDA Device Recall Z-0293-2024: Philips North America Llc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0293-2024.

Recall Res Number

Z-0293-2024

Recalling Firm / Manufacturer

Philips North America Llc

FEI Number

3016618143

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-10-09

Date Posted

2023-11-14

Date Terminated

N/A

Product Code

JAK

Event Number

93291

Product Quantity

11 units

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

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.

Action Details 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).

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

Code Information / Serial Numbers UDI-DI: (01)00884838059450 Serial Numbers: 760012 7742 75043 76137 76005 7830 76202 76134 76038 7871 7825

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Medical Device Recall: Z-0293-2024

Recall Parameters & Description

Related Establishments / Registrations

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