—#41690

Product

GE Signa Advantage nuclear magnetic resonance imaging system.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
PMA numbers: P830074
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2005-08-19
Posted by FDA: 2006-05-10
Terminated: 2007-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41690. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.