Z-0360-2012

Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003...

Name: Z-0360-2012 Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2011-09-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-09-06 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a... on 2011-09-06. The reason FDA records is "Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due to software...". 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-0360-2012
Status: Terminated
Initiated: 2011-09-06
Posted: 2011-12-02
Terminated: 2013-03-15
Recalling firm: Philips North America LLC
Product: Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference 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: Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due to software errors identified in these device systems.
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare released a 'Field Change Order' (FCO #72800542) on September 15, 2011. Philips sent an URGENT - Medical Device Correction letter dated October 10, 2011, to all affected customers. The letter listed the affected device systems; described the nature of the software problem; and any possible hazard inherent to the situation. The letter was mailed by Philips to their customers on October 27, 2011. The letter provided information telling the customer how to identify the affected products and what action to take. In this instance, the customer was asked to review the Customer Release Notes which were provided to each customer location once the software update was installed. The letter notified the customer that a Philips representative would be installing a software upgrade in order to address the referenced software issues free-of-charge, through a Field Change Order. The letter closes by providing information which all customers in Canada and North America can use to contact the firm through a toll-free telephone number 1-800-722-9377, option 5; enter side ID or follow the prompts. For questions regarding this recall call 440-483-4918.
Quantity in commerce: 5 units
Distribution: Worldwide Distribution - USA including Ohio and the countries of Australia, China, Belgium, Israel, and Sweden
Product codes and lots: Model #728231, 510(k) #KK033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157.

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)