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Recall Observatory FDA recall evidence

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

July 25, 2012

Class II

Product summary

Firm
Philips Healthcare Inc.
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

    reason.no_named_rule · v1.0.0

    Essenta DR C-Arm may fall