Class 2 Device Recall GE Healthcare Discovery MR750 3.0T

• Date Initiated by Firm: November 18, 2010
• Date Posted: February 18, 2011
• Recall Status: Terminated on February 04, 2012
• Recall Number: Z-1375-2011
• Recall Event ID: 57270
• 510(K)Number: K081028
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: GE Healthcare Discovery MR750 3.0T The GE Signa MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa MR750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including, but not limited to, head, neck, TMVJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa MR750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa MR750 System are similar to those for the Signa HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System.
• Code Information: 00000XRMBB0092 00000XRMBB0093 00000XRMBB0098 00000XRMBB0102 00000XRMBB0103 00000XRMBB0106 00000XRMBB0108 00000XRMBB0113 00000XRMBB0115 00000XRMBB0117 00000XRMBB0128 00000XRMBB0134 00000XRMBB0112 00000XRMBB0107 00000XRMBB0076 00000XRMBB0061 00000XRMBB0116 00000XRMBB0077 00000XRMBB0097 00000XRMBB0062 00000XRMBB0130 00000XRMBB0118 00000XRMBB0124 00000XRMBB0095 00000XRMBB0105
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-513-4122
• Manufacturer Reason for Recall: GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR systems that may impact service or maintenance personnels safety. The gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the g
• FDA Determined Cause: Nonconforming Material/Component
• Action: GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 16, 2011, to all affected customers. The letter was addressed to Hospital Administrator / Risk Manger, Radiology Department Manager and Maintenance / Biomedical Engineering Department. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction and Contact Information. Customers were instructed to follow appropriate lockout/tagout (LOTO) procedures. Customers were instructed to contact GE Healthcare engineering at 843-687-7213 or 843-697-3009 for instructions on how to proceed. For questions concerning the notiifcaton customers were instructed to contact their local Support Engineer.
• Quantity in Commerce: 25
• Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, LA, MD, MA, MI, MO, NV, NJ, NY, NC, OR, PA, SC, TN, TX, WA, WI. and the countries of AUSTRALIA, BRAZIL, CANADA, EHYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, ITALY, JAPAN, KUWAIT, QATAR, REPUBLIC OF KOREA, SWITZERLAND, TAIWAN, and the UNITED KINGDOM.UNITED KINGDOM, TAIWAN, SWITZERLAND, REPUBLIC OF KOREA, QATAR, KUWAIT, JAPAN, ITALY, INDIA, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, CANADA, BRAZIL, AUSTRALIA.
• 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