Z-0636-2007

Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)

Name: Z-0636-2007 Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2006-10-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2006-10-02 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1) on 2006-10-02. The reason FDA records is "Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0636-2007
Status: Terminated
Initiated: 2006-10-02
Posted: 2007-03-17
Terminated: 2012-03-26
Recalling firm: Philips North America LLC
Product: Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
Reason for recall: Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data.
FDA root cause: Other
Action: Customer advisory notification letters dated 10/4/06 and 10/25/06 were sent to consignees providing short term work around instructions. Software modifications installed by the recalling firm will follow as the long term correction.
Quantity in commerce: 17 units
Distribution: Class II Recall-Nationwide Distribution-USA including states of KY, MD, TX, RI, NJ, MA, LA, VA, PA, SC, CA, OH, and FL.
Product codes and lots: Serial numbers 7009, 7056, 7060, 7066, 7069, 7072, 7079, 7088, 7111, 7112, 7113, 7114, 7117, 7118, 7119, 7121, 7125.

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)