Recall Z-1188-2017 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
Discovery MR450 The systems are whole body magnetic resonance scanners 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, incl
| Date | Feb 10, 2017 (initiated Jan 20, 2017) |
| Status | Terminated |
| Reason | Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn. |
| Root cause | Device Design |
| Action | The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter GEHC Ref# 60913 Dated January 20, 2017. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 60 |
| Distribution | Worldwide Distribution- US (nationwide) including states of: CA, DC, IL, MN, MO, NY, SC, TX, WI, WV; and countries of: Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132376 | DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T Ge Healthcare (Ge Medical Systems, LLC), Nov 15, 2013 |
| K142085 | DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T Ge Medical Systems, LLC, Sep 26, 2014 |
| K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T Ge Medical Systems, LLC, Jun 9, 2016 |