FDA Recall
Terminated
Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
Recall: Z-0636-2007
·
Initiated October 2, 2006
Recall
- Recall Number
- Z-0636-2007
- Event Number
- 36685
- Firm
- Philips Medical Systems (Cleveland) Inc
- FEI Number
- 1525965
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 2, 2006
- Posted
- March 17, 2007
- Terminated
- March 26, 2012
- Address
- 595 Miner Road, Cleveland, OH, 44143-2131
Description
Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
Reason
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.
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.
Distribution
Class II Recall-Nationwide Distribution-USA including states of KY, MD, TX, RI, NJ, MA, LA, VA, PA, SC, CA, OH, and FL.
Quantity
17 units