Z-0111-2008

Brilliance CT Systems 64 slice configuration. Computed tomography scanner

Name: Z-0111-2008 Brilliance CT Systems 64 slice configuration. Computed tomography scanner
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2007-05-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-05-25 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance CT Systems 64 slice configuration. Computed tomography scanner on 2007-05-25. The reason FDA records is "Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis". 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-0111-2008
Status: Terminated
Initiated: 2007-05-25
Posted: 2007-10-31
Terminated: 2012-09-24
Recalling firm: Philips North America LLC
Product: Brilliance CT Systems 64 slice configuration. Computed tomography scanner.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis.
Root cause tag: software
FDA root cause: Software design
Action: Firm notified its customers via a Product Safety Notification letter dated May 25, 2007, warning the user of a possible appearance of artifacts which could lead to a misdiagnosis and improper treatment.
Quantity in commerce: 633
Distribution: Worldwide, including USA, Canada, Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Denmark, Ecuador, Egypt, England, Equatorial Guinea, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Korea, Lebanon, Libya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Phillipines, Poland, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, Uzbekistan, Venezuela, and West Indies.
Product codes and lots: Model No. 728235. Version 2.2.1

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