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Class 2 Device Recall Philips Essenta DR, XRay System |
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Date Initiated by Firm |
July 25, 2012 |
Date Posted |
August 15, 2012 |
Recall Status1 |
Terminated 3 on March 01, 2013 |
Recall Number |
Z-2207-2012 |
Recall Event ID |
62650 |
510(K)Number |
K070528
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Product Classification |
System, x-ray, stationary - Product Code KPR
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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 MA 01810
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For Additional Information Contact |
978-687-1501
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Manufacturer Reason for Recall |
Essenta DR C-Arm may fall
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS GMBH, DMC
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