Spectral CT on Rails, Software Version 5.1.0, Model Number… recallZ-0319-2024 · 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

This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).

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. Remain vigilant and confirm gantry position during procedures. Review the Emergency Stop Procedure and Collision Prevention Guidelines provided in Section 6: Working with Specialized Exams of the IFU. 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-0319-2024
Status: Open, Classified
Initiated by the company: Oct 9, 2023
Posted by the FDA: Nov 16, 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.

How recalls are matched to devices · Editorial policy · Report an error on this page