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U.S. Department of Health and Human Services

Class 2 Device Recall Performix

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  Class 2 Device Recall Performix see related information
Date Initiated by Firm December 08, 2003
Date Posted January 08, 2004
Recall Status1 Terminated 3 on November 15, 2005
Recall Number Z-0306-04
Recall Event ID 27927
510(K)Number K013561  K023988  
Product Classification Tube Mount, X-Ray, Diagnostic - Product Code IYB
Product Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.
Code Information Tube Catalog #''s D3132, D3172, D3182, and D3152 used on Gantry model #''s 2137130, 2137130-5, 2234921-3, 2260619, 2260619-3, 2281177, 2281177-2, 2281177-3, 2281177-4, 2305500, 2339985, 2341799, 2362605, and 5101272.
Recalling Firm/
General Electric Med Systems
3000 N Grandview Blvd
Waukesha WI 53188-1615
Manufacturer Reason
for Recall
Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.
FDA Determined
Cause 2
Action Field Modification Instructions (FMI''s) will be issued to the field to inspect and locate suspect tubes and replace any that may be susceptible to failure.
Quantity in Commerce 400
Distribution Distributed nationwide throughout the US 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 = IYB and Original Applicant = GE MEDICAL SYSTEMS