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Class 2 Device Recall Phillips Endura XRay Systems |
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Date Initiated by Firm |
August 23, 2007 |
Date Posted |
November 10, 2007 |
Recall Status1 |
Terminated 3 on September 27, 2010 |
Recall Number |
Z-0060-2008 |
Recall Event ID |
39392 |
510(K)Number |
K919435
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Product Classification |
Fluoroscopic Image-Intensified System - Product Code JAA
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Product |
Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option |
Code Information |
Serial numbers: 90, 105, 118, 119, 135, 171, 175, 176, 222, 218, 227, 226, 232, 233, 241, 248, 249, 256, 261, 262, 276, 277, 282, 303, 302, 316, 313, 304, 311, 312, 320, 327, 334, 333, 343, 345, 396 |
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 Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.
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FDA Determined Cause 2 |
Software design |
Action |
On 8/23/07, the firm sent out a Safety Notification letter, via certified mail. On 8/29/07, the firm sent out an URGENT - DEVICE CORRECTION letter via regular mail, dated 8/20/07. Both letters advised customers that if the device shuts down during use, it can be restarted within about 1 minute by switching the system off and then on again, using the system on/off buttons. The letter(s) states that software is being developed to correct the problem. |
Quantity in Commerce |
37 units |
Distribution |
Nationwide |
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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