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 quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command.
This recall has been terminated (originally issued December 27, 2013).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- December 5, 2013
- Posted
- December 27, 2013
- Terminated
- January 17, 2017
- Recall Number
- Z-0584-2014
- Quantity
- 424 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
X-ray system C-arm casting may loosen and fall
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, Lithuania, Morocco, Netherlands, New Zealand, Nigeria, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Arab, United Kingdom and Viet nam.
Lot / Code Info
All Essenta DR x-ray Systems
Root Cause
Nonconforming Material/Component
Action Taken
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.