Recall Z-0584-2014 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems, Inc.
Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to qui
| Date | Dec 27, 2013 (initiated Dec 5, 2013) |
| Status | Terminated |
| Reason | X-ray system C-arm casting may loosen and fall |
| Root cause | Nonconforming Material/Component |
| Action | Philips Medical Systems issued a Urgent Field Safety Notice-Warning Label and Inspection, dated November 21, 2013, advising of potential of C-arm detaching and requesting a daily inspection and a safety warning label . If you need any further information or support concerning this issue, please contact your local Philips representative. 1-800-722-9377. |
| Quantity | 424 units |
| Distribution | Worldwide Distribution - USA (Nationwide) including Puerto Rico and the countries of : Afghanistan, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hungary, India, Indonesia Iran,Italy, Jordan, Kazakstan, Kenya, Liberia, Lithuan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070528 | PHILIPS ESSENTA DR Philips Medical Systems GmbH, Dmc, Mar 9, 2007 |