Recall Z-2207-2012 ยท KPR System, X-Ray, Stationary
Philips Healthcare Inc.
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): 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.
| Date | Aug 15, 2012 (initiated Jul 25, 2012) |
| Status | Terminated |
| Reason | Essenta DR C-Arm may fall |
| Root cause | Equipment maintenance |
| Action | Philips Medical sent an "URGENT FIELD SAFETY NOTICE" dated July 09, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers are asked to inspect the C-Arm unit and discontinue use if not parallel to the column, do not use the system and call for a Service Technician. A Field Change Order (FCO) is being released that requires an inspection of C-ARM connection and, if necessary, repair of systems. The bolts will be disconnected and thread inserts will be checked. If not the thread inserts are no longer secured, additional h |
| Quantity | 7 units |
| Distribution | Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary. |
| 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 |