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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.

FDA Recall Z-2527-2018 · Posted None

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2018-03-30
Date Terminated2024-03-29
Product Quantity54 units total

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMGe Medical Systems, LLC · 2004-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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