Class 2 Device Recall Performix

• Date Initiated by Firm: December 08, 2003
• Date Posted: January 08, 2004
• Recall Status: Terminated 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/ Manufacturer: 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: 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

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