GE Healthcare, Discovery MR750w
Recall
- Recall Number
- Z-2131-2016
- Event Number
- 74442
- Firm
- GE Healthcare, LLC
- FEI Number
- 2126677
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 8, 2016
- Terminated
- October 4, 2018
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
GE Healthcare, Discovery MR750w
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.
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.
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 Indonesia Ireland Italy Japan Kazakhstan Korea (Republic of) Kuwait Lebanon Mexico Netherlands New Zealand Poland Qatar Romania Russia Russian Federation Saudi Arabia Singapore Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay
471 (184 US; 287 OUS)