Z-0306-2024Class II

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

Name: Z-0306-2024 Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Creator: Philips North America
Published: 2023-10-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-10-09 / Open, Classified / root cause: software

FDA source

Philips North America began a recall of Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 on 2023-10-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0306-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-09
Posted: 2023-11-15
Recalling firm: Philips North America LLC
Product: Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: 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).
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of MN.
Product codes and lots: UDI-DI: 00884838103627; Lot Code: 1005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0306-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0306-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-15

Product code JAK

K212875Class IISpectral CT on RailsPhilips Medical Systems Nederland B.V. / cleared 2022-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)