| Class 2 Device Recall Definium AMX 700 | |
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 |
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 |
Manufacturer Reason for Recall | When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely. |
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
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