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U.S. Department of Health and Human Services

Class 2 Device Recall MR Surgical Suite Option

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  Class 2 Device Recall MR Surgical Suite Option see related information
Date Initiated by Firm March 30, 2018
Create Date July 23, 2018
Recall Status1 Terminated 3 on March 29, 2024
Recall Number Z-2527-2018
Recall Event ID 80287
510(K)Number K041476  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product 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.
Code Information 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)
Recalling Firm/
GE Medical Systems, LLC
3200 N Grandview Blvd
Waukesha WI 53188-1693
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Nonconforming Material/Component
Action GE Healthcare notified customers on about 03/30/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter informed customers that the MR Surgical Suited System could still remain in use, it referred them to the GE MR Surgical Suite Operator's Manual for detailed descriptions of the various safety interlocks and operating mechanisms, encouraged users to monitor for any issues releasing the transfer board from the GE MR Surgical Table, and instructed users to test the patient transfer features as part of a quality check prior to each use. The letter also informed customers that a GE Healthcare representative will contact customers to ensure they have the latest operator manual at their site, update preventative maintenance documentation to include a procedure that focuses specifically on this equipment, and GE Healthcare representative will contact customers for scheduling a visit at which time GEHC will conduct this preventative maintenance procedure for their device and install new hardware. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your the Service Representative.
Quantity in Commerce 54 units total
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS, LLC