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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Essenta DR

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 Class 2 Recall
Philips Essenta DR
see related information
Date Posted December 27, 2013
Recall Status1 Open
Recall Number Z-0584-2014
Recall Event ID 67012
Premarket Notification
510(K) Number
K070528 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray 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.
Code Information All Essenta DR x-ray Systems
Recalling Firm/
Manufacturer
Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover, Massachusetts 01810-1032
For Additional Information Contact SAME
978-687-1501
Manufacturer Reason
for Recall
X-ray system C-arm casting may loosen and fall
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Philips Medical Systems issued a Urgent Field Safety Notice-Warning Label and Inspection, dated November 21, 2013, advising of potential of C-arm detaching and requesting a daily inspection and a safety warning label . If you need any further information or support concerning this issue, please contact your local Philips representative. 1-800-722-9377.
Quantity in Commerce 424 units
Distribution Worldwide Distribution - USA (Nationwide) including Puerto Rico and the countries of : Afghanistan, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hungary, India, Indonesia Iran,Italy, Jordan, Kazakstan, Kenya, Liberia, Lithuania, Morocco, Netherlands, New Zealand, Nigeria, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Arab, United Kingdom and Viet nam.
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 = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS GMBH, DMC
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