Z-0674-2013Class II

Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and...

Name: Z-0674-2013 Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-12-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-12-03 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By... on 2012-12-03. FDA classified it as Class II and gives the reason as "Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If...". 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-0674-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-03
Posted: 2013-01-15
Terminated: 2013-06-18
Recalling firm: Philips North America LLC
Product: Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are 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 analysis and display equipment, patient, and equipment supports, components and accessories.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Philips Healthcare, sent an 'URGENT- Medical Device Correction" letters' dated November 15, 2012, and December 3, 2012, to their customers. Both letters describe the product, problem and actions to be taken. The letters state that Philips is notifying all affected customers of this information via a 'Field Safety Notice and will be installing a software update on the affected Brilliance 64 and Ingenuity CT system in order to address these issues. A Philips' Field Service Engineer will be contacting each customer site and make arrangements to install the necessary software update on these device systems. The customers should contact their local Philips representative or local Philips Healthcare office. In North America and Canada needing further information or support concerning this update, should contact our Customer Care Solutions Center at 1-800-722-9377. Selection option 5, and enter their site ID or follow the prompts.
Quantity in commerce: A total of nine (9) units were distributed (3 units in the U.S & 6 units overseas)
Distribution: Worldwide distribution: USA including IN, OH and OR; and the countries: Australia, Belgium, China, Israel, and Sweden.
Product codes and lots: Brilliance CT X-RAY System - Model/System Code #728231, Serial Number distributed in the U.S. was: 9654. Ingenuity CT X-Ray System - Model/System Code #728326 - Serial Numbers distributed in the U.S. were: 300018, and 300003. The remaining Serial Numbers distributed overseas were: 91003, 95130, 95157, 95504, and Serial Numbers: 300010, and 300030 .

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0674-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0674-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-15

Product code JAK

K033326Class IIPhilips Plus Computed Tomography SystemPhilips Medical Systems, Inc. / cleared 2003-10-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)