Recall Z-2131-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
GE Healthcare, Discovery MR750w
| Date | Jun 8, 2016 |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent on 6/8/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 60901 dated June 8, 2016. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 471 (184 US; 287 OUS) |
| Distribution | US: AK, AZ, CA, COM, CT , DC, FL, GA, GU, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH,OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY. OUS: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bermuda Brazil Bulgaria Canada China Egypt France Germany Hungary India |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103327 | DISCOVERY MR750W 3.0T Ge Healthcare Japan Corporation, Sep 30, 2011 |
| K130115 | DISCOVERY MR750W 3.0T Ge Medical Systems, LLC, May 23, 2013 |
| 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 |