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Class 2 Device Recall Performix |
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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
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Product Classification |
Tube Mount, X-Ray, Diagnostic - Product Code IYB
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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/ Manufacturer |
General Electric Med Systems 3000 N Grandview Blvd Waukesha WI 53188-1615
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Manufacturer Reason for Recall |
Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.
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FDA Determined Cause 2 |
Other |
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
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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 = IYB and Original Applicant = GE MEDICAL SYSTEMS
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