Device Recall IntelliVue

  • Model / Serial
    Serial Numbers: US73900100 US73900101 US73900102 US73900103 US73900104 US73900105 US73900106 US73900107 US73900108 US73900109 US73900110 US73900111 US73900112 US73900113 US73900114 US73900115 US73900116 US73900117 US73900118 US73900119 US73900120 US73900121 US73900122 US73900123 US73900124 US73900125 US73900126 US73900127 US73900128 US73900129 US73900130 US73900131 US73900132 US73900133 US73900134 US73900135 US73900136 US73900137 US73900138 US73900140  US73900141 US73900142 US73900143 US73900144 US73900145 US73900146 US73900147 US73900148 US73900149 US73900150 US73900151 US73900153 US73900154 US73900155 US73900156 US73900157 US73900158 US73900159 US73900160 US73900161 US73900162 US73900163 US73900164 US73900165 US73900166 US73900167 US73900168 US73900169 US73900170 US73900171 US73900172 US73900173 US73900174 US73900175 US73900176 US73900177 US73900178 US73900179 US73900180 US73900181 US73900182 US73900183 US73900184 US73900185 US73900186 US73900187 US73900188 US73900189 US73900190 US73900191 US73900192 US73900193 US73900194 US73900195 US73900197 US73900198 US73900199 US73900200 US73900201 US73900202, and  US73900203.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Belgium, China, Denmark, France, Germany, Ireland, Italy, Kenya, Malaysia, Netherlands, Singapore, Spain, Switzerland, Taiwan, UAE, and UK.
  • Product Description
    Philips IntelliVue Clinical Information Portfolio || Software Version D.0, for patient data collection, storage, and management.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

6 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    IntelliVue Patient Monitor || Product Usage: || The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
  • Manufacturer
  • Model / Serial
    Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States: Nationwide Foreign Countries: Germany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norway, Czech Republic, Poland, Italy, Singapore, Denmark, Iceland, India, Saudi Arabia, Ireland, Oman, Bahrain, Japan, Israel, Malaysia, South Africa, Turkey, Thailand, Latvia, Bulgaria, Indonesia, Slovenia, United Arab Emirates, Hong Kong, Aruba, Chile, Lebanon, Korea, Kuwait, Taiwan, Argentina, Hungary, Luxembourg, Mexico, Gabon
  • Product Description
    IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
  • Manufacturer
  • Model / Serial
    Softwarre versions: C.00.00 through C.00.06
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Canada, Australia, Austria, Belgium, Denmark., France, Finland, Germany, Great Britain, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, and UAE
  • Product Description
    CareVue Chart Release C ,Versions C.00.00 through C.00.06 || Product No. 862246. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage.
  • Manufacturer
  • Model / Serial
    Version D.00.00
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Canada, Australia, Austria, Belgium, Denmark., France, Finland, Germany, Great Britain, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, and UAE
  • Product Description
    IntelliVue Clinical Information Portfolio || Critical Care Release D, Version D.00.00 || Product Number: 865047. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage.
  • Manufacturer
  • Model / Serial
    Serial Numbers: DE22701289 - DE843 16576
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Canada, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, Bosnia, BRAZIL, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRI, LITHUANIA, LUXEMBOURG, MACAU, MALAYSIA, MAURITIUS, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA & MONTE NEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, United Arab Emirates, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, VIRGIN ISLANDS (BR), and YEMEN.
  • Product Description
    Philips Intellivue Patient Monitor Model MP60 (M8005A)
  • Manufacturer
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