Recall Z-0858-06 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems, LLC
GE Signa Advantage nuclear magnetic resonance imaging system.
| Date | May 10, 2006 (initiated Aug 19, 2005) |
| Status | Terminated |
| Reason | 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 | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.