FDA-Device2012-08-22Class II
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 posi
Philips Healthcare Inc.
Hazard
Essenta DR C-Arm may fall
Sold states
Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary.
Affected count
7 units
Manufactured in
3000 Minuteman Road, Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2207-2012Don't want to check this manually?
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