Z-1324-2025Class II

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

Name: Z-1324-2025 Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334
Creator: Philips Medical Systems Nederland B.V.
Published: 2025-02-28
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2025-02-28 / Open, Classified / root cause: software

FDA source

Philips Medical Systems Nederland B.V. began a recall of Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334 on 2025-02-28. FDA classified it as Class II and gives the reason as "Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement". 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-1324-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-28
Posted: 2025-03-12
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: On February 28, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users. " You may continue to use your system(s) in accordance with the intended use and by following the recommendation listed below. " When you see the warning message No communication with table and C-arm. Avoid collisions, Proceed with caution., acknowledge the message by selecting OK and continue using the CT while observing with extra care, collision with the Gantry and C-arm can be avoided. " To protect the patient and the operator from a potential collision due to an automatic gantry motion during scan and plan box not updated during interventional procedure issues, follow the instructions mentioned in the IFU Section 4 Preparing for an Examination and Sub section Gantry Operation: o During all movements of the gantry (automatic and manual), keep the patient under continuous observation. o Take care to avoid pressing the patient against the gantry or between table parts, as well as to avoid disconnecting any infusion or resuscitation apparatus. o For all patient table types, take care when using attachments to avoid collision with the gantry. o Make sure that the patient is strapped securely to avoid dangling of the hands. Ensure that the patient is placed securely on the patient table and is not in danger of falling. o Auto scan means that automatic motions are expected without using the enable button. Ensure the patient table does not collide with the gantry during movement. o During studies, the gantry movements (if applicable) are automatic. Ensure enough clearance between the patient and the gantry. Before initiating the scan, perform manual movements to check the clearance. " To avoid cone beam auto correction artifacts: 1) Reduce the collimation to 32 for brain study, or reduce the collimation to 112 (or any value below 128) for body imaging, which will turn CBAC off. Refer t
Quantity in commerce: 1 unit
Distribution: Domestic: MN
Product codes and lots: Software Version Number 5.1.0; Model number: 728334; UDI-DI: (01)00884838103627(21)1005; Serial Number (SN): 1005;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1324-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1324-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-12

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)