Z-0236-2015Class II

Philips Brilliance iCT Computed Tomography X-Ray System

Name: Z-0236-2015 Philips Brilliance iCT Computed Tomography X-Ray System
Creator: Philips Medical Systems, Inc.
Published: 2014-07-31
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-07-31 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to... on 2014-07-31. FDA classified it as Class II and gives the reason as "It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location". 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-0236-2015
Classification: Class II
Status: Terminated
Initiated: 2014-07-31
Posted: 2014-12-16
Terminated: 2017-02-16
Recalling firm: Philips North America LLC
Product: Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips Healthcare is directly notifying affected users via letter. In addition, Philips Healthcare has performed the software correction for forward production and plans a Field Correction to fix the defect in the field. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.
Quantity in commerce: 16 systems
Distribution: US Distribution
Product codes and lots: Software version 4.1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0236-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0236-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16

Product code JAK

K060937Class IIBrilliance VolumePhilips Medical Systems (Cleveland), Inc. / cleared 2006-06-05

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)