Recall Z-0365-2016 ยท KPR System, X-Ray, Stationary
Philips Medical Systems, Inc.
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
| Date | Aug 19, 2014 |
| Status | Terminated |
| Reason | The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient. |
| Root cause | Device Design |
| Action | The Field Safety Notice FCO70600086 will be mailed on August 19, 2014. Philips Medical Systems will send out certified letters and will have the receipts returned for tracking purposes as well as have a Field Service Engineer visit each site to provide the fix when the Field Change Order is released. |
| Quantity | 260 units, not all units have the patient support accessory |
| Distribution | Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031535 | PHILIPS EASYDIAGNOST ELEVA Philips Medical Systems North America Co., Jun 17, 2003 |