Worldwide Distribution -- US, to the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and to the territories of Guam and Puerto Rico; and, countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, German, Ghana, Greece, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, UAE, and Vietnam.
Worldwide Distribution -- US, to the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and to the territories of Guam and Puerto Rico; and, countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, German, Ghana, Greece, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, UAE, and Vietnam.
Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Description du dispositif
Philips Medical: || 865047 IntelliVue Clinical Information Portfolio Release D.03 || 865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01 || 865300 IntelliVue Clinical Information Portfolio NICU Link || Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
Models with SW Revision H (up to and including H.15.36) are affected, upgraded between October 6, 2010 and January 23, 2012 MP20 (M8001A), MP30 (M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), D80 (M8016A), MX600 (865242), MX700 (865241) MX800 (865240
Worldwide Distribution -- USA (nationwide) and the countries of ALBANIA, ANGOLA, ANTILLES, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BYELORUSSIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, GHANA, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LEBANON, LIBYAN, ARAB, JAMAHIRI, LITHUANIA, LUXEMBOURG,MACAU, MALAYSIA, MOROCCO, MAURITIUS, MEXICO, MOROCCO, NAMIBIA, NEPAL, NETHERLANDS, ANTILLES, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PALESTINE, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB, EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIET NAM, YEMEN, ARAB REP and ZAMBIA
Description du dispositif
Philips IntelliVue Patient Monitors: || The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. The monitor is to be used by trained health care professionals. Physiological Monitoring, Patient Monitor , Arrhythmia detector and alarm (including ST -segment measurement and alarm.
PIIC 865435 M3140 Information Center Low Acuity 865436 M3150 Information Center Local DB 865417 M3145 Information Center Small NW DB 865418 M3155 Information Center NW DB 865415 M3151 Information Center Client 865421 M3170 Patient Link 865416 M3177 Trend Display 865422 M3140 Upgrade 865423 M3150 Upgrade 865426 M3145 Upgrade 865427 M3155 Upgrade 865424 M3151 Upgrade 865266 - M3140 Information Center Low Acuity 865267 M3150 Information Center Local DB 865269 M3145 Information Center Small NW DB 865268 M3155 Information Center NW DB 865270 M3151 Information Center Client 865274 M3170 Patient Link 865271 M3177 Trend Display 865277 M3140 Upgrade 865278 M3150 Upgrade 865281 M3145 Upgrade 865282 M3155 Upgrade 865279 M3151 Upgrade PIIC iX 866023 IntelliVue Info Center iX 866117 PIIC Classic Upgrade 866027 PIIC iX HW Upgrade
Worldwide Distribution - USA (nationwide) and Canada.
Description du dispositif
Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX || The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.