GE Signa Advantage nuclear magnetic resonance imaging system.

FDA device recall Z-0858-06 · posted 2006-05-10 · Terminated

Recall details

Recalling firm

GE Medical Systems, LLC

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LNH

Quantity affected

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, Kor

Date initiated

2005-08-19

Date posted

2006-05-10

Date terminated

2007-02-03

Location

Waukesha, WI