Z-0858-06

GE Signa Advantage nuclear magnetic resonance imaging system

Name: Z-0858-06 GE Signa Advantage nuclear magnetic resonance imaging system
Creator: GE Medical Systems, LLC
Published: 2005-08-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-08-19 / Terminated

FDA source

GE Medical Systems, LLC began a recall of GE Signa Advantage nuclear magnetic resonance imaging system on 2005-08-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0858-06
Status: Terminated
Initiated: 2005-08-19
Posted: 2006-05-10
Terminated: 2007-02-03
Recalling firm: GE Healthcare
Product: GE Signa Advantage nuclear magnetic resonance imaging system.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
FDA 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 in commerce: 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
Product codes and lots: 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

Product code LNH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)