Z-2223-2012Class II

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

Name: Z-2223-2012 The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-07-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-07-18 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer... on 2012-07-18. FDA classified it as Class II and gives the reason as "1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did...". 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-2223-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-18
Posted: 2012-08-17
Terminated: 2013-02-22
Recalling firm: Philips North America LLC
Product: The Brilliance 64 and Ingenuity CT 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: 1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable Dose Check after ente
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an URGENT - Medical Device Correction letter date July 18, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Phillips will be installing a software update version 4.0.0xx516. A Philips Service Engineer will contact the customer for implementation of the software update on the affected systems free of charge. For further information or support concerning this issue, customers may contact their local Philips representatives or Philips Healthcare office. For North America and Canada, they may also contact the Customer Care Solutions Center (1-800-722-9377, option 5) For questions regarding this recall call 440-483-7000.
Quantity in commerce: 8
Distribution: Worldwide Distribution - USA including IN and OH, also, the countries of Australia, Belgium, China, Israel, and Sweden
Product codes and lots: System Code # 728231, Serial #s: 91003, 95157, 9654, 95130, and 95504 System Code # 728326, Serial #s: 300010, 300030, and 300018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2223-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2223-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-17

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)