—#95714

Product

GE Healthcare Discovery MR450 1.5T, The Discovery MR450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It 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/or functions 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. Depending on the region of interest being imaged, contrast agents may be used; The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: 00000XRMBB0091 00000XRMBB0101 00000XRMBB0096 00000XRMBB0111 00000XRMBB0100 00000XRMBB0063 00000XRMBB0094 00000XRMBB0099 00000XRMBB0121 00000XRMBB0122 00000XRMBB0125

Why it was recalled

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 grad

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-11-18
Posted by FDA: 2011-02-18
Terminated: 2012-02-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95714. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.