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Terminated

GE Signa Advantage nuclear magnetic resonance imaging system.

FDA Recall Z-0858-06 · Posted 2006-05-10

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2005-08-19
Date Terminated2007-02-03
Product Quantity644 (516 US, 128 OUS)

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.

Firm 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.

Root Cause

Other

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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