Spectral CT on Rails, Software Version 5.1.0, Model Number… recallZ-0306-2024 · Philips North America · initiated Oct 9, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Philips North America or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT Medical Device Correction notification letter dated 10/9/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users. Below are short-term precautions to take until the permanent solution is installed. Leave the audible preparation indication alert turned on, set as default in the factory settings, and wait for the audible alert before pressing the foot pedal. If you have disabled the audible alert, you can turn it back on by following instructions provided in Section 4: Preparing for an Examination of the IFU. Wait for the blue arrow to appear on the screen on the console and in the procedure room, prior to depressing the fluoroscopy pedal. 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. Actions planned by Philips to correct the problem 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 72800805) to resolve the issue. Please be assured that maintaining a high level of safety and quality is our highest priority. 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-0306-2024
Status: Open, Classified
Initiated by the company: Oct 9, 2023
Posted by the FDA: Nov 15, 2023
Recalling firm: Philips North America
Quantity: 1 unit
Product code: JAK
FDA submissions: K212875
Distribution: US Nationwide distribution in the state of MN.

Product description

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Code information (models, lots, serial numbers)

UDI-DI: 00884838103627; Lot Code: 1005

Devices named in this recall

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

Spectral CT on Rails
Philips Medical Systems Nederland B.V. · System, X-Ray, Tomography, Computed
6 recalls0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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