Z-0121-2008

The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software...

Name: Z-0121-2008 The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2007-09-27
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-09-27 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC)... on 2007-09-27. The reason FDA records is "The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain...". 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-0121-2008
Status: Terminated
Initiated: 2007-09-27
Posted: 2007-11-07
Terminated: 2012-03-02
Recalling firm: Philips North America LLC
Product: The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient orientations and view conventions when saved for later viewing.
Root cause tag: software
FDA root cause: Software design
Action: Notification letters were sent to the installed customer base informing them of the hazard on 10/1/2007. A mandatory corrective software release due out mid October 2007, will be available at no cost to the customer. The software will be installed by Philips Field Service Engineers.
Quantity in commerce: 206 systems
Distribution: Worldwide, including USA, Canada, France, Finland, Korea, Australia, Italy, Switzerland, China, Austria, Thailand, Malaysia, Denmark, Norway, Jordan, Netherlands, England, South Africa, Spain, Germany, Bahrain, Belgium, New Zealand, Puerto Rico, South Korea, Saudi Arabia, Czech Republic, Sweden, Israel, and Lithuania
Product codes and lots: All Brilliance CT Big Bore Scanners with Tumor Localization software versions v2.2.1, v2.2.2, & v2.2.5. This software version is included on Brilliance CT Big Bore Scanners, Model Number 728243, and Serial Numbers 7001 - 7215.

Product code JAK

K033357Class IIAcqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. / cleared 2004-01-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)