Z-1067-2012

GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). The MR Surgical Option when integrated with the...

Name: Z-1067-2012 GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). The MR Surgical Option when integrated with the...
Creator: GE Healthcare, LLC
Published: 2011-12-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-12-15 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). The MR Surgical Option when integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner... on 2011-12-15. The reason FDA records is "GE Healthcare has recently become aware of a potential safety issue due to the failure of the transfer board release lever associated with the OR Compatible patient transfer table of your Optima MR450w MR Surgical Suite". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1067-2012
Status: Terminated
Initiated: 2011-12-15
Posted: 2012-02-21
Terminated: 2012-05-29
Recalling firm: GE Healthcare
Product: GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). The MR Surgical Option when integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution, high signal-to-noise ratio, with short scan times. The Signa Excite MR system with Surgical Option is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa" Excite system with Surgical Option reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The GE Signa" Excite system with Surgical Option can provide MR images at various stages of a surgical procedure, and provides the capability to transfer a patient to the MR system table directly from a surgical table, or patient transport system. Images can be obtained using the MR scanner body coil, or local surface coils, and the surface coils used with the integrated system may/can accommodate sterile draping for surgical procedures.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: GE Healthcare has recently become aware of a potential safety issue due to the failure of the transfer board release lever associated with the OR Compatible patient transfer table of your Optima MR450w MR Surgical Suite.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: GE Healthcare, sent a Urgent Medical Device Correction letter dated December 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed discontinue use of OR Compatible table until issue is corrected. GE Healthcare will correct all affected systems by providing a replacement table cradle incorporating design changes to the cradle release lever mechanism at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. Contact your local service representative if you have any questions concerning this notification. For further questions please call (262) 513-4122.
Quantity in commerce: 2
Distribution: Worldwide Distribution -- USA including Wisconsin and the country of Austria.
Product codes and lots: 12051M69 12228M63

Product code LNH

K043262Class IIGe Signa Excite Mr Surgical OptionGE Healthcare / cleared 2005-01-12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)