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U.S. Department of Health and Human Services

Class 2 Device Recall Definium AMX 700

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  Class 2 Device Recall Definium AMX 700 see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = GENERAL ELECTRIC MEDICAL SYSTEMS
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