Z-0840-2018Class II

Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243

Name: Z-0840-2018 Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2018-01-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-01-03 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce... on 2018-01-03. FDA classified it as Class II and gives the reason as "Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0840-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-03
Posted: 2018-03-02
Terminated: 2019-07-02
Recalling firm: Philips North America LLC
Product: Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated January 2, 2018 to their customers. The letter identified the affected product problem and actions to be taken. For questions contact your local Philips representative or local Philips Healthcare office.
Quantity in commerce: 11
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: Brilliance Big Bore Oncology CT, Model # 728243 Serial #s: 76025 76022 76024 76023 76016 76021 76008 76010 76002 76020 76011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0840-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0839-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02
Z-0840-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02

Product code JAK

K033357Class IIAcqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. / cleared 2004-01-09

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)