Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60751
  • Event Risk Class
    Class 2
  • Event Number
    Z-1067-2012
  • Event Initiated Date
    2011-12-15
  • Event Date Posted
    2012-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106393
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    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.
  • 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.

Device

Device Recall GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite).
  • Model / Serial
    12051M69 12228M63
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including Wisconsin and the country of Austria.
  • Product Description
    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.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA