Class 2 Device Recall GE

• Date Initiated by Firm: March 30, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on July 24, 2006
• Recall Number: Z-0853-04
• Recall Event ID: 28753
• 510(K)Number: K760466 K801320
• Product Classification: Screen, Intensifying, Radiographic - Product Code EAM
• Product: GE Single 20 inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number B2056EG
• 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: The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
• FDA Determined Cause: Other
• Action: Field modification instructions were issued on 3/30/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to hospitals.
• Quantity in Commerce: 1236 devices
• 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 = EAM