Recall Z-0553-2016 ยท MOS Coil, Magnetic Resonance, Specialty
GE Medical Systems, LLC
GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
| Date | Dec 28, 2015 (initiated Dec 7, 2015) |
| Status | Terminated |
| Reason | Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent on 12/7/2015 a GE Healthcare "Urgent Medical Device Correction" GEHC Ref#60888 letter dated December 7, 2015. 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 and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. UPDATE: Consignees were sent a revised letter on May 2, 2016. Previously the letter only listed MR750W Surgical Suite Sca |
| Quantity | 90 (54 US; 36 OUS) |
| Distribution | Worldwide Distribution- US Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, VA, DE, FL, MD, ME, MO, NC, NH, OR, PA, TN, WI, DC, PR and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWIT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110610 | 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL Ge Medical Systems, LLC, Apr 1, 2011 |