Recall Z-1377-2011 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
GE Healthcare, Optima MR450w 1.5T MR systems 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 i
| Date | Feb 18, 2011 (initiated Nov 18, 2010) |
| Status | Terminated |
| Reason | 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 personnel's safety. The gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the gra |
| Root 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 p |
| Quantity | 68 |
| 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, SWIT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091536 | OPTIMA MR450W Ge Medical Systems, LLC, Jul 17, 2009 |