Class 2 Device Recall GE Advantx

• Date Initiated by Firm: March 24, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on July 24, 2006
• Recall Number: Z-0897-04
• Recall Event ID: 28747
• 510(K)Number: K890348
• Product Classification: System, X-Ray, Angiographic - Product Code IZI
• Product: Advantx 1 LC1 Model 45258230 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: 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