Z-1054-2024Class II

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

Name: Z-1054-2024 Spectral CT on Rails: Software Version 5.1.0.X, model 728334
Creator: Philips Medical Systems
Published: 2023-12-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-12-13 / Open, Classified / root cause: labeling and UDI

FDA source

PHILIPS MEDICAL SYSTEMS began a recall of Spectral CT on Rails: Software Version 5.1.0.X, model 728334 on 2023-12-13. FDA classified it as Class II and gives the reason as "A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1054-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-13
Posted: 2024-02-08
Recalling firm: Philips North America LLC
Product: Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: US: 1
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 codes and lots: UDI-DI: 00884838103627, serial number: 1005.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1054-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1054-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-08
Z-1055-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-08

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)