Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
FDA Recall Z-0636-2007 · Posted 2007-03-17
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Date Initiated2006-10-02
Date Terminated2012-03-26
Product Quantity17 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Class II Recall-Nationwide Distribution-USA including states of KY, MD, TX, RI, NJ, MA, LA, VA, PA, SC, CA, OH, and FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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