Z-2206-2011

Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity...

Name: Z-2206-2011 Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2011-03-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-03-07 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity CT. The recalled units are equipped with software... on 2011-03-07. The reason FDA records is "A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants". 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-2206-2011
Status: Terminated
Initiated: 2011-03-07
Posted: 2011-05-19
Terminated: 2013-02-22
Recalling firm: Philips North America LLC
Product: Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity CT. The recalled units are equipped with software versions: 3.5.21028 and 3.5.25028. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants.
Root cause tag: software
FDA root cause: Other
Action: A 'Field Safety Notice - Urgent - Medical Device Correction' notification was sent to the firm's customers via Certified mail on 3/8/2011. The notification letter explains the nature of the Metal Artifact Reduction/Metal Artifact Correction software error; the Brilliance CT X-Ray systems subject to correction and how to identify them; and the circumstances under which this error can occur. It also asks that the user stop running the MAR application on any of the affected Brilliance systems identified with the recalled serial numbers and software versions alluded to in the medical device correction notification. Lastly, the notification states that Philips Medical will provide a solution that will fix the issue and the notification lists contact names; telephone numbers; and E-mail addresses which the customer can contact for further information concerning this device issue, or customer support assistance.
Quantity in commerce: 10 units
Distribution: Nationwide Distribution -- DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, and VT.
Product codes and lots: The following Serial Numbers of the Brilliance 64 (including Ingenuity CT) are subject to recall/software correction: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005, and 300010.

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)