Philips Spectral CT on Rails. Model Number: 728334 recallZ-1825-2026 · Philips Medical Systems · initiated Mar 7, 2026

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 Medical Systems 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

Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.

FDA root cause category: Under Investigation by firm

What the company is doing

Philips Medical notified consignees on about 03/07/2026 via letter. Consignees were instructed to identify any affected systems in inventory and specifically for each issue: 1. Issue #1: Ensure to follow the instructions mentioned in the IFU Section 4 Preparing for an Examination and Sub section Gantry Operation. 2. Issue #2: Avoid the Select Previous Surview Unavailable issue, manually remove the patient's middle name while importing the patient detail from HIS/RIS. 3. Issue #3: if Define Head Area option is grayed out with DoseRight Index (DRI) on, review the dose levels displayed on the User Interface, confirm and adjust the dose settings to appropriate levels before executing the scan as instructed in the IFU. Consignees were also instructed to complete and return the response form, to circulate the Urgent Medical Device Correction Letter to all users of the affected device so that they are aware of the issues, and retain the letter with affected system(s) until a solution is installed on each system; ensure the letter is in a place likely to be seen/viewed. Philips will contact each consignee to schedule a time for a Philips Field Service Engineer (FSE) to visit each site and install the solution to resolve the issues (reference FCO72800830).

Recall details

Recall number: Z-1825-2026
Status: Open, Classified
Initiated by the company: Mar 7, 2026
Posted by the FDA: Apr 16, 2026
Recalling firm: Philips Medical Systems
Quantity: 3 systems
Product code: JAK
FDA submissions: K212875
Distribution: Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.

Product description

Philips Spectral CT on Rails. Model Number: 728334.

Code information (models, lots, serial numbers)

Model Number: 728334. UDI: (01)00884838103627(21)1005, (01)00884838103627(21)1006, (01)00884838103627(21)1007. Software Version Number: 5.1.X. Serial Numbers: 1005, 1006, 1007.

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