• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Definium AMX 700

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Definium AMX 700
see related information
Date Posted May 22, 2007
Recall Status1 Terminated on February 24, 2008
Recall Number Z-0821-2007
Recall Event ID 37848
Premarket Notification
510(K) Number
K052879 
Product Classification System, X-Ray, Mobile - 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, Wisconsin 53188-1693
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
DESIGN: Device Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = ZIMMER, INC.
-
-