Z-2664-2014Class II

The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional...

Name: Z-2664-2014 The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2011-09-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-09-01 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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... on 2011-09-01. FDA classified it as Class II and gives the reason as "During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of...". 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-2664-2014
Classification: Class II
Status: Terminated
Initiated: 2011-09-01
Posted: 2014-09-18
Terminated: 2015-07-01
Recalling firm: Philips North America LLC
Product: 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: During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. Philips has disabled this feature at all sites evaluating 4.0 Beta 2 software. Philips will issue a software up
Root cause tag: software
FDA root cause: Software design
Action: The firm, Philips, sent a Field Safety Notice (FSN 72800534) entitled "URGENT-Medical Device Correction" dated September 1, 2011 via mail on September 6, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to review the following information with all members of your staff who need to be aware of the contents of this communication and retain a copy with the equipment Instructions for Use. A Field Service Engineer will visit each site to install the corrected software. 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: 6
Distribution: Worldwide Distribution: US distribution in OH and countries of: Australia, China, Belgium, Israel, and Sweden.
Product codes and lots: 91003, 30018, 95504, 300004, 300030, 300010, 95130, 95157

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2664-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2664-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-18

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)