Spectral CT on Rails: Software Version 5.1.0.X, model 728334 recallZ-1054-2024 · Philips Medical Systems · initiated Dec 13, 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 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

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

FDA root cause category: Under Investigation by firm

What the company is doing

An Urgent Medical Device Correction notice (2023-PD-CTAMI-017) dated December 13, 2023 was issued via Certified Mail. Philips Field Service Engineers will contact customers to schedule an onsite visit to install update software correcting the issue. Customers are asked to complete and return the response form and circulate the notice to all users of the device for awareness. Contact Philips Customer Care Solutions Center 1-800-722-9377 with questions.

Recall details

Recall number: Z-1054-2024
Status: Open, Classified
Initiated by the company: Dec 13, 2023
Posted by the FDA: Feb 8, 2024
Recalling firm: Philips Medical Systems
Quantity: US: 1
Product code: JAK
FDA submissions: K212875
Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.

Product description

Spectral CT on Rails: Software Version 5.1.0.X, model 728334.

Code information (models, lots, serial numbers)

UDI-DI: 00884838103627, serial number: 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

Other products in the same recall event

The FDA groups related products into one recall event (event 93798).

Z-1055-2024 · Open, Classified
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

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