Upgrade Spectral CT SW5.4Recalls & reported problems

Philips Medical Systems Nederland B.V. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Aug 21, 2026Open, Classified
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
Z-0078-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Device details

UDI-DI	`00884838127876`
Brand	Upgrade Spectral CT SW5.4
Model	Upgrade Spectral CT SW5.4
Catalog no.	728375
Company	Philips Medical Systems Nederland B.V.
Product code	JAK · System, x-ray, tomography, computed
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 8, 2026

Device type (GMDN): Full-body CT system

An assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Other System, x-ray, tomography, computed devices

ARTIS icono biplane 11327600
Siemens Healthcare GmbH · System, x-ray, tomography, computed
15 recalls2 deaths55 reports
ARTIS icono floor 11327700
Siemens Healthcare GmbH · System, x-ray, tomography, computed
15 recalls24 reports
Incisive CT
Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed
13 recalls5 reports
Spectral CT
Philips Medical Systems Nederland B.V. · System, x-ray, tomography, computed
11 recalls3 reports
Incisive CT
Philips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed
9 recalls20 reports
Brilliance iCT
Philips Medical Systems Nederland B.V. · System, x-ray, tomography, computed
8 recalls6 reports
Revolution Apex Elite
GE Medical Systems, L.L.C. · System, x-ray, tomography, computed
8 recalls0 reports
Brilliance CT Big Bore
Philips Medical Systems Nederland B.V. · System, x-ray, tomography, computed
7 recalls1 report

All System, x-ray, tomography, computed devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page