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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Essenta DR, XRay System

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 Class 2 Recall
Philips Essenta DR, XRay System
see related information
Date Posted August 15, 2012
Recall Status1 Terminated on March 01, 2013
Recall Number Z-2207-2012
Recall Event ID 62650
Premarket Notification
510(K) Number
K070528 
Product Classification System, X-Ray, Stationary - Product Code KPR
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.
Code Information Serial Numbers: SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Essenta DR C-Arm may fall
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
Action Philips Medical sent an "URGENT FIELD SAFETY NOTICE" dated July 09, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers are asked to inspect the C-Arm unit and discontinue use if not parallel to the column, do not use the system and call for a Service Technician. A Field Change Order (FCO) is being released that requires an inspection of C-ARM connection and, if necessary, repair of systems. The bolts will be disconnected and thread inserts will be checked. If not the thread inserts are no longer secured, additional holes will be drilled to use in place of the original ones. For further information or support concerning this issue, contact your local Philips representative at 1-800-722-9377.
Quantity in Commerce 7 units
Distribution Worldwide Distribution-USA including the states of CA, NC, and TN and the countries of China, Germany, and Hungary.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS GMBH, DMC
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