Z-0832-2014Class II

Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The...

Name: Z-0832-2014 Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2013-12-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-12-09 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed... on 2013-12-09. FDA classified it as Class II and gives the reason as "Patient images exhibited ring artifacts". 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-0832-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-09
Posted: 2014-01-27
Terminated: 2014-05-29
Recalling firm: Philips North America LLC
Product: Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Patient images exhibited ring artifacts.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Philips Healthcare, sent an "URGENT - Medical Device Correction" letter dated December 9, 2013 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following to avoid the occurrence of these specific ring artifacts: 1. Disable Automatic Scan Time for all Exam Cards 2. Leave Automatic Scan Time on during planning and prior to clicking Go to initiate the scan, click the acquisition series of the scan and disable Automatic Scan Time, then proceed with the scan. 3. Disable Edit Before Final Recon (Reconstruction) for all Exam Cards If a ring artifact is present, clinical judgment should be used by the customer/user to determine if the images acquired in the dataset contain enough information to make a diagnosis. Philips will be releasing a Field Change Order (FCO) to correct the issue with software version release 4.1.1.19261. In addition, a Philips Field Service Engineer will contact you to schedule the software installation at your site. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).
Quantity in commerce: 7 units
Distribution: Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel.
Product codes and lots: Brilliance iCT: 728306, Serial #'s: 100018, 100040, 100411, 100503, 100506 Brilliance iCT SP: 728311, Serial #'s: 200047, 200121

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0832-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0832-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27

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)