Device product
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. 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 arm.
Z-2207-2012
Product summary
- Event
- Event 62650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-2207-2012
Official wording
Reason: Essenta DR C-Arm may fall
Code information: Serial Numbers: SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050
Distribution pattern: Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary.
Derived failure modes
-
Unknown
Essenta DR C-Arm may fall