Recall Z-0623-2009 ยท KPR System, X-Ray, Stationary
Philips Medical Systems North America Co. Phillips
Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher Used for general R/F, fluoroscopy, radiography, and angiography examinations.
| Date | Sep 25, 2009 (initiated Dec 30, 2008) |
| Status | Terminated |
| Reason | System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid switch leakage may occur. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | A Customer Notification letter describing the failure, the means, by which a customer can prevent the failure mode from occurring, and actions planned by Philips to correct the problem were sent to all users of the affected systems. Philips will modify the system software and will be installed at no cost to the customer. |
| Quantity | 30 systems |
| Distribution | Nationwide distribution including states CA, CO, IA, ID, KS, MN, NC, NJ, NY, OH, SC, TX, UT, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050151 | MULTIDIAGNOST ELEVA Philips Medical Systems North America, Inc., Feb 9, 2005 |