BEUDAMED
    FDA Enforcement Class II Terminated

    MR Surgical Suite Option Product 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 tile surface coils used with the integrated system may / can accommodate sterile draping for surgical procedures.

    Recall: Z-2527-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2527-2018
    Event ID
    80287
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2018
    Initiation Date
    March 30, 2018
    Classification Date
    July 23, 2018
    Termination Date
    March 29, 2024
    Address
    3200 N Grandview Blvd, N/A, Waukesha, WI, 53188-1693, United States

    Description

    MR Surgical Suite Option Product 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 tile surface coils used with the integrated system may / can accommodate sterile draping for surgical procedures.

    Reason

    There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that allows the patient to be moved from the GE MR Surgical Table to the Maquet Magnus Surgical Table.

    Code Info

    Model Numbers M8074SS, M8053SS, M0074SS, M0001SS, 5265300-7, 5265300-8. Serial Number (System ID Number): 00000000000002 (602406IMR), 4295404 (4295404MR11), N/A (415UCBHMR3), N/A (720848MR4), 00000304124MR1 (904202MR8), N/A (309655IMRI), 4425007 (913588NMRW), 00000000UA0117 (616267IMRI), 00000000000003 (507284NMRV), 4311497 (MR229054), 4510086 (212636SIGNA3T), 00000000UA0116 (330344MR750W), UA0326 (614293MR9), N/A (614RMHTMR1), 4371613 (412692MR750W), N/A (214820ITABLE), 4250114 (409772MR6), 4550641 (4550641MR11), 4482037 (757388750WMR), 00000012228M63 (608263MR4IOR), 4356151 (414805IMR1), 00000299229MR5 (AH5824MR01), 00000012051M69 (AH5824SS01), 00000021158M61 (MRHM0885), 00000014131M67 (MRHM0323), 00000018480M64 (MR307144MR6), 4565719 (082427110075), 00000013254M68 (082445160014), 000000PTST0008 (082427040101), 000000PTST0007 (082427050024), 4596631 (082427310113), 4409769 (082427140133), 000000PTST0003 (CS1020MR01), DUMFMI60885001 (CS1006MR03), 00001309FMM07L (T4185506), 00000021695M62 (M4194477), 00000021695M62 (X41944020), 00000305145MR5 (UC2547MR01), 4320023 (083027822002316), 4508956 (A5381507), 00000010003M62 (EM0293), 00001219FMM0H1 (EM0105), 00000017217M61 (EM0105), 000000PTST0010 (YM3833), 00000000000004 (YM1733), 2937140 (0850270414), 4548529 (KW1008MR08), 000000PTST0006 (ZA2169MR01), 00001251FMM044 (34368MRS01), 4344097 (34418MRS01), 4605737 (N/A), 000000PTST0005 (10590MRS01), DUMFMI60885002 (10590MRS02), 4569734 (00132MRS01)

    Distribution

    US Nationwide distribution to AZ, CA, CO, FL, IL, KS, MI, MN, NY, OH, PA, TX, UT, VA, WI. Worldwide distribution to Austria, Brazil, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, South Africa, Turkey, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    54 units total