U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
System,network and communication,physiological monitors - Product Code MSX
원인
Ge healthcare is providing information about two issues associated with icentral l-neto5 and l-netc05 v4.3, 4.4, 4.5 and 5.0 when used in combination with dash 2000, 3000, 4000 and 5000; solar 7000, 8000, 8000m and 8000i; eagle 3000 and 4000 and apexpro. the icentral does not provide audio or visual alarming for the following: a fib, vt> and pvc(1) alarms when used with apexpro and vt>2 and pvc.
조치
Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated January 26, 2009 addressed to Healthcare Administrator/Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the safety issue, affected product details, safety instructions, product correction and contact information. Direct questions to GE Healthcare at 1-800-558-7044, Option 2 and ask for Technical Support or contact your local GE Healthcare Distributor.
Worldwide Distribution, USA (and PR) including states of AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY,LA, ME, MI, MN, MS, MO, NH, NJ, NY, NC, OH, PA, SC, TX, VT, VA, WA, and WI and countries of AUSTRALIA, AUSTRIA, BARBADOS, BELGIUM, BOLIVIA, BRASIL, BULGARIA, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GAYANA, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LIBYAN ARAB JAMAHIRIYA, MACEDONIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, PAKISTAN, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SLOVEN IA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, SYRIA ARAB REPUBLIC, THAILAND, TUNAS IA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA and YEMEN.
제품 설명
GE Healthcare, S/5 iCentral and iCentral Client, || Related to software licenses L-NET05 and L-NETC05, Datex-Ohmeda Inc., PO Box 7550 Madison, WI 53707-7550, USA, GE Healthcare Finland Oy, Helsinki, Finland PO Box 900. FI-00031 GE. || The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other network devices in Monitor Network. Network connection consists of hardwire network and/or wireless LAN (WLAN) connection. The iCentral can be used for remote monitor management, storage, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other network devices. The Dates-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is to be used by qualified personnel only.