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U.S. Department of Health and Human Services

Class 2 Device Recall GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite).

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 Class 2 Recall
GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite).
see related information
Date Posted February 21, 2012
Recall Status1 Terminated on May 29, 2012
Recall Number Z-1067-2012
Recall Event ID 60751
Premarket Notification
510(K) Number
K043262 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
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.
Code Information 12051M69 12228M63
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GE HEALTHCARE
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