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.
Failure to alarm: an active monitor could become disconnected from the unit without any notification or alarm.
조치
Consignees were notified via a Medical Device Correction letter on 12/13/07. The letter explained the circumstances in which the "connection to monitor loss" alarm would not display, if a monitor was disconnected. The letter also included an attachment entitled "How to ensure a 'Connection to monitor lost' alarm on iCentral." For additional information, contact 1-800-558-7044.
Worldwide Distribution including USA states of AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, PA, SC, TN, TX, VA, VT, WA and WI; and countries of Algeria, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Guans, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libyan, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Yemen.
제품 설명
S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwatosa, WI 53226.