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U.S. Department of Health and Human Services

Class 2 Device Recall GE Advantx

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  Class 2 Device Recall GE Advantx see related information
Date Initiated by Firm March 24, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 24, 2006
Recall Number Z-0899-04
Recall Event ID 28747
510(K)Number K890348  
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Advantx 1 LC2 Model 2105657 Angiographic X-ray System
Code Information All serial numbers
Recalling Firm/
Manufacturer
General Electric Med Systems
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Larry A. Kroger
262-544-3894
Manufacturer Reason
for Recall
Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.
FDA Determined
Cause 2
Other
Action Field modification instructions were issued on 3/24/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to the hospitals.
Distribution The units were distributed nationwide in the United States and worldwide.
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 = IZI and Original Applicant = GENERAL ELECTRIC CO.
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