GE Medical Systems, LLC GE Signa Advantage nuclear magnetic resonance imaging system. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.