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Class 2 Device Recall MultiDiagnost Eleva with Flat Detector (MDE FD) |
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Date Initiated by Firm |
December 30, 2008 |
Date Posted |
September 25, 2009 |
Recall Status1 |
Terminated 3 on September 28, 2010 |
Recall Number |
Z-0623-2009 |
Recall Event ID |
50748 |
510(K)Number |
K050151
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Product Classification |
Stationary X-Ray System - Product Code KPR
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Product |
Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher
Used for general R/F, fluoroscopy, radiography, and angiography examinations. |
Code Information |
software version 4.3.1 or higher. Units are identified with Site Numbers: 538440, 542581, 543228, 543846, 543886, 544123, 544124, 544904, 545113, 545114, 548112, 551714, 553435, 553838, 554283, 554284, 554633, 554640, 556369, 557258, 41445127, 41445131, 41445800, 41455927, 41643223, 41849575, 42549980, 42799914, and 41445927. |
Recalling Firm/ Manufacturer |
Philips Medical Systems North America Co. Phillips 22100 Bothell Everett Hwy Bothell WA 98021-8431
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For Additional Information Contact |
425-487-7602
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Manufacturer Reason for Recall |
System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid switch leakage may occur.
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FDA Determined Cause 2 |
Radiation Control for Health and Safety Act |
Action |
A Customer Notification letter describing the failure, the means, by which a customer can prevent the failure mode from occurring, and actions planned by Philips to correct the problem were sent to all users of the affected systems. Philips will modify the system software and will be installed at no cost to the customer. |
Quantity in Commerce |
30 systems |
Distribution |
Nationwide distribution including states CA, CO, IA, ID, KS, MN, NC, NJ, NY, OH, SC, TX, UT, VA, and WI. |
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 NORTH AMERICA, INC.
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