Device Recall Philips Healthcare

  • Model / Serial
    S/N: 3490 3056 3298 3249 3338 3354 3297 3394 3313 3429 3421 3434 3430 3430 3461 3487
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Canada,Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, South Africa, Spain, Switzerland and United Kingdom.
  • Product Description
    Philips Healthcare Xper cardio systems || Model : 722123 || Product Usage: || The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

79 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial Number Range US11149477 - US11149503 US11149741 - US11149795 US11149798 - US11149883 US11149886 - US11149932 US11149935 - US11149959 US11149961 - US11149967 US11150078 - US11150124 US11150162 - US11150177 US11150196 - US11150307 US11150312 - US11150315 US11150336 - US11150343 US11150345 - US11150546
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and countries of ARAB JAMAHIRI, AUSTRIA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, CANADA ,CHILE, COLOMBIA, CROATIA, CYPRUS, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, KUWAIT, LEBANON, LIBYAN, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA ,SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    Philips SureSigns VM Series Patient Monitors: || VM4, VM6, VM 8: || Model Part Numbers || VM4 863063, 453564024371, 453564021961, 453564024401, 453564021971 || VM6 863064, 863065, 453564024421, 453564022001, 453564024441, 453564022041 || VM8 863066, 863068, 453564022081, 453564024461, 453564024481 || The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
  • Manufacturer
  • Model / Serial
    Serial Number Range CN04400000 - CN04499999 US10200000 - US10299999 CN03700000 - CN03799999 CN04400000 - CN04499999 CN10200000 - CN10299999 US03800000 - US03899999 US04400000 - US04499999 US10200000 - US10299999
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and countries of ARAB JAMAHIRI, AUSTRIA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, CANADA ,CHILE, COLOMBIA, CROATIA, CYPRUS, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, KUWAIT, LEBANON, LIBYAN, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA ,SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    Philips SureSigns VS3 Vital Signs Monitor Models: || VS3 863069, 863070, 453564041251, 453564041261, || VS3 863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301 || The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
  • Manufacturer
  • Model / Serial
    Software version 1.2 Models: 732040, 732042, 732044, 732048, 732050, 732052, 732080, 732082
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide distribution; and including the countries of Albania, Angola, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Croatia, Denmark, Egypt, France, Germany, Ghana, Greece, Greece, Haiti, Hungary, Indonesia, Iraq, Israel, Italy, Kazakhstan, Kenya, Latvia, Libya, Liechtenstein, Lithuania, Malawi, Malta, Martinique, Mexico, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Portugal, Puerto Rico, Romania, Russia, Saudi-Arabia, Serbia, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Tanzania, Thailand, Tschech. Rep, Turkey, Turkmenistan, UAE, Uganda, and United Kingdom.
  • Product Description
    PCR Eleva Radiological Image Processing System with software R.1.2 || Philips Healthcare, Inc. || A computed radiography image processing system.
  • Manufacturer
  • Model / Serial
    MultiDiagnost Eleva II - 708036, 708032,  MultiDiagnost Eleva FD - 708037, 708034,
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Product Description
    Philips Healthcare MD Eleva system. || Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications
  • Manufacturer
  • Model / Serial
    Software release 2.0.2 and 2.0.2SP1 including mirror icon
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Canada AFGHANISTAN ALBANIA ALGERIA ANGOLA ARGENTINA ARMENIA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BAHRAIN BANGLADESH BARBADOS BELARUS BELGIUM BENIN BHUTAN BOLIVIA BOSNIA&HERZEGOVINA; BRAZIL BRUNEI DARUSSALAM BULGARIA BURUNDI CAMBODIA CAMEROON CANARY ISLANDS CHAD CHILE CHINA COLOMBIA CONGO CONGO,DEMOCRATIC COSTA RICA COTE D'IVOIRE CROATIA CUBA CYPRUS CZECH REPUBLIC DENMARK DJIBOUTI DOMINICAN REPUBLIC ECUADOR EGYPT EL SALVADOR EQUATORIAL GUINEA ERITREA ESTONIA ETHIOPIA fake test ssd FINLAND FRANCE FRENCH GUIANA GABON GAMBIA GEORGIE GERMANY GHANA GREECE GUADELOUPE GUAM GUATEMALA GUINEA GUYANA HONDURAS HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAMAICA JAPAN JORDAN KAZAKSTAN KENYA KUWAIT KYRGYZSTAN LAO PEOPLE'S DEM.REP LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRI LIECHTENSTEIN LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAWI MALAYSIA MALI MALTA MARTINIQUE MAURITANIA MAURITIUS METRACOM MEXICO MOLDOVA MONGOLIA MOROCCO MOZAMBIQUE NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORTH KOREA NORWAY OMAN PAKISTAN PALESTINE PANAMA PARAGUAY PERU PHC BEST PHILIPPINES PMCC BU Canada PMCC BU USA POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA RWANDA SAUDI ARABIA SENEGAL SERBIA&MONTE; NEGRO SIERRA LEONE SINGAPORE SLOVAKIA SLOVENIA SOMALIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SUDAN SURINAME SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN TAJIKISTAN TANZANIA THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE Unidentified Country UNITED ARAB EMIRATES UNITED KINGDOM URUGUAY UZBEKISTAN VENEZUELA VIET NAM YEMEN ZAMBIA ZIMBABWE
  • Product Description
    Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon || Stationary Fluoroscopic system
  • Manufacturer
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