Z-1825-2026Class II

Philips Spectral CT on Rails. Model Number: 728334

Name: Z-1825-2026 Philips Spectral CT on Rails. Model Number: 728334
Creator: Philips Medical Systems
Published: 2026-03-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2026-03-07 / Open, Classified / root cause: software

FDA source

PHILIPS MEDICAL SYSTEMS began a recall of Philips Spectral CT on Rails. Model Number: 728334 on 2026-03-07. FDA classified it as Class II and gives the reason as "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...". 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-1825-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-07
Posted: 2026-04-16
Recalling firm: Philips North America LLC
Product: Philips Spectral CT on Rails. Model Number: 728334.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: 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).
Quantity in commerce: 3 systems
Distribution: Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1825-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1825-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-16

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)