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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product Description 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.
Recall Number Z-2207-2012
Classification Class II
Code Info Serial Numbers: SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050
Product Distributed Qty 7 units
Reason For Recall Essenta DR C-Arm may fall

Event Detail

Event Id 62650
Product Type Devices
Status Ongoing
Recalling Firm Philips Healthcare Inc.
City Andover
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary.