Device Recall CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION 의 리콜

Cardiovascular Devices

2

No

Worldwide Distribution including US (states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, PR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WY, WI, and WV) and countries of UNITED ARAB EMIRATES, AUSTRIA, AUSTRALIA, BOSNIA AND HERZEGOVINA, BANGLADESH, BELGIUM, BRAZIL, BAHAMAS, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, CUBA, CYPRUS, CZECH REPUBLIC, GERMANY, ESTONIA, EGYPT, SPAIN, FINLAND, FRANCE, GHANA, GREECE, HONG KONG, HUNGARY, HONDURAS, INDONESIA, IRELAND, ISRAEL, INDIA, IRAQ, BRITISH INDIAN OCEAN TERRITORY, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, MALTA, MEXICO, MALAYSIA, NIGERIA, NETHERLANDS, NORWAY, NEPAL, NEW ZEALAND, PANAMA, PERU, PHILIPPINES, PAKISTAN, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SUDAN, SW DEN, SINGAPORE, SLOVENIA, SLOVAK REPUBLIC, SYRIA, THAILAND, TURKEY, TRINIAD, TOBAGO, TAIWAN, UKRAINE, UNITED KINGDOM, VENEZUELA, YEMEN, and SOUTH AFRICA.

GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1. || The CIC Pro" Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro Central Station is intended to collect information from a network and display this data. This data included physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from GE Healthcare Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information central station. Beat to beat patient information for all parameters and waveforms from he bedsides and telemetry systems can be displayed. The CIC Pro Clinical Information Center central station supports the ability to access information from GE Medical Systems Information Technologies products in web browser format. Additionally, the CICC Pro clinical Information central station supports the ability to access patient information collected from the unity network and stored on a network server.