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Class 2 Device Recall Definium AMX 700 |
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Date Initiated by Firm |
December 21, 2006 |
Date Posted |
May 22, 2007 |
Recall Status1 |
Terminated 3 on February 24, 2008 |
Recall Number |
Z-0821-2007 |
Recall Event ID |
37848 |
510(K)Number |
K052897
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Product Classification |
mobile x-ray system - Product Code IZL
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Product |
Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI |
Code Information |
973971AMXD1, 973971AMXD2, 402449CDP1, 402449CDP2, 601426DAMX1, and 972566D700A |
Recalling Firm/ Manufacturer |
GE Medical Systems LLC 3200 N Grandview Blvd Waukesha WI 53188-1693
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For Additional Information Contact |
262-544-3894
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Manufacturer Reason for Recall |
When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.
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FDA Determined Cause 2 |
Other |
Action |
Visit to each consignee beginning December 21, 2006. |
Quantity in Commerce |
6 units |
Distribution |
Product was distributed in the following states: MS, NE, NJ, and, TX |
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 = IZL and Original Applicant = GENERAL ELECTRIC MEDICAL SYSTEMS
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