Class 2 Device Recall GE Signa Advantage

• Date Initiated by Firm: August 19, 2005
• Date Posted: May 10, 2006
• Recall Status: Terminated on February 03, 2007
• Recall Number: Z-0858-06
• Recall Event ID: 33320
• PMA Number: P830074
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: GE Signa Advantage nuclear magnetic resonance imaging system.
• Code Information: All GE Signa Advantage MRI magnets with the model numbers 46-260805G1, 46-260805G2, 46-281380G1, 46-281380G2, 46-281380G3, 46-281380G4, 46-281380G5, 46-281380G6, 46-281380G7 and 46-281380G8
• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: During use of GE Signa nuclear magnetic resonance imaging system, a flexible Teflon tube that was part of the magnet vent system ruptured and allowed the magnet to vent into the scan room. Because of helium pressure inside the room, the scan room door could not be reopened after the patient was removed from the scan room.
• FDA Determined Cause: Other
• Action: GE Healthcare is issuing an Urgent Safety Notification to all affected customer sites beginning 09/01/05. The notification describes the concurrent condition that must exist in order for the event to occur. Users are warned to be present at all times when scanning patients and to take emergency measures to vent the scan room should the magent quench. Beginning September 2005, all affected customers'' devices will have the Teflon venting tube replaced with a nonflexible venting tube.
• Quantity in Commerce: 644 (516 US, 128 OUS)
• Distribution: Nationwide and to countries OUS including: United Arab Emirates, Argentina, Australia, Brazil, Canada, China, Germany, Denmark, Egypt, Spain, France, United Kingdom, Ireland, Italy, Jordan, Japan, Korea, Kuwait, Lebanon, Luxembourg, Mexico, Netherlands, Saudi Arabia, Sweden, Turkey and Tiawan
• 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.

• PMA Database: PMAs with Product Code = LNH