Z-0815-2007

GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System

Name: Z-0815-2007 GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System
Creator: GE Medical Systems LLC
Published: 2006-06-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-06-01 / Terminated / root cause: software

FDA source

GE Medical Systems LLC began a recall of GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System on 2006-06-01. The reason FDA records is "To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0815-2007
Status: Terminated
Initiated: 2006-06-01
Posted: 2007-05-18
Terminated: 2008-02-24
Recalling firm: GE Healthcare
Product: GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.
Root cause tag: software
FDA root cause: Other
Action: The corrective action is already completed and all customers have been notified via a personal visit to each site, to install a software patch beginning June, 2006.
Quantity in commerce: 30 units
Distribution: Worldwide, including USA, China, Finland, Germany, Israel, Italy, Korea, Spain, and Taiwan.
Product codes and lots: 00000249264MR3, 00000257756MR7, 00000255196MR8, 00000246630MR8, 00000259107MR1, 00000248178MR6, 00000257451MR5, 00000256200MR7, 00000260871MR9, 00000252451MR0, 00000259108MR9, 00000254480MR7, 00000254482MR3, 00000256198MR3, 00000249263MR5, 00000250755MR6, 00000251090MR7, 00000GE0131001, 00000GE0213040, 00000254375MR9, 00000GE0205028, 00000GE0210034, 00000227995MR8, 00000GE0212037, 00000GE0226049, 00000GE0410083, 00000260871MR9, 00000GE0234057, 00000GE0123041, 00000GE0302068

Product code LNH

K040444Class IIGe Signa 3.0T with Excite Mr SystemGeneral Electric Co. / cleared 2004-04-14

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)