Device Recall Philips Healthcare

  • Model / Serial
    Serial Numbers within the range of US00442485 through US00469873.   The following additional units are also affected because their energy select switches were replaced within the relevant time period: Serial Numbers:  US00100353 US00110688 US00121145 US00338153 US00100741 US00110914 US00121658 US00439208 US00100843 US00111399 US00123159 US00439504 US00101080 US00112143 US00124026 US00439652 US00101500 US00112685 US00125012 US00439661 US00102492 US00114680 US00125049 US00439688 US00102580 US00114900 US00125344 US00439930 US00102583 US00116677 US00126424 US00441252 US00102601 US00116965 US00127322 US00441758 US00102643 US00117003 US00127620 US00441855 US00103225 US00118060 US00213344 US00441862 US00103916 US00118260 US00213559 US00104178 US00118602 US00230434 US00105134 US00118915 US00230588 US00106329 US00118985 US00231849 US00106922 US00119444 US00232228 US00108281 US00119624 US00232394 US00108296 US00120241 US00233505 US00109777 US00120466 US00234442 US00110403 US00120589 and US00234615.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- UNITED STATES, CANADA, ALBANIA, ARGENTINA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY,GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN,KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACAU, MACEDONIA, MALAYSIA,MALI, MARTINIQUE, MAURITIUS, MEXICO, MONGOLIA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU,PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO,ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA,THAILAND, TRINIDAD AND TOBAGO, TURKEY,TUNESIA, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, VIRGIN ISLANDS and YEMEN.
  • Product Description
    HeartStart XL Model M4735A Defibrillator, Automatic, External || Defibrillator-Monitor. || The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
  • Manufacturer
  • 1 Event

Manufacturer

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

79 devices with a similar name

Learn more about the data here

  • Model / Serial
    This action affects all customers who were shipped an MRx unit from 2/11/2004 through 06/25/2010
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: CANADA AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOSNIA&HERZEGOVINA; BRAZIL BRUNEI DARUSSALAM BULGARIA CHILE CHINA COLOMBIA CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KUWAIT LATVIA LEBANON LIBYAN ARAB JAMAHIRI LITHUANIA LUXEMBOURG MACEDONIA MALAYSIA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA SAUDI ARABIA SERBIA&MONTE; NEGRO SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM VENEZUELA VIET NAM YEMEN
  • Product Description
    HeartStart MRx Defibrillator/Monitor || Models: M3535A / M3536A / M3536J / M3536MC || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
  • Manufacturer
  • Model / Serial
    Site Numbers: 104075, 104497, 537745, and 51333258.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including states of CA, IL, MA, NC, and OC.
  • Product Description
    Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allura CV20. || Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
  • Manufacturer
  • Model / Serial
    Site Numbers: 103331, 520481, 537743, 43721190, 43796227, 51126900, and 51333259.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including states of CA, IL, MA, NC, and OC.
  • Product Description
    Allura XPER FD 20 and and Allura CV20; || Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura CV20. || Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
  • Manufacturer
  • Model / Serial
    Model/Serial Number Range:  Model M3535A: US00100100 to US00578696 Model M3536A: US00100902 to US00576650 Model M3536J: US00209838 to US00332675 Model M3536M: US00500002 to US00553553 Model M3536MC: US00500001 to US00500087 Model M3536M2: US00554176, US00554177, US00554178 Model M3536M4: US00500003 to US00574869 Model M3536M5: US00500001 to US00562935 Model M3536M6: US00554358 to US00576619
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GHANA, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, Jordan, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LAOS, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACAU, MACEDONIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, MOZAMBIQUE, MYANMAR (Burma), NAMIBIA, NEPAL, NETHERLANDS, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, UNITED REPUBLIC OF TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    HeartStart MRx monitor/defibrillator || Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 || Product Usage: || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
  • Manufacturer
  • Model / Serial
    System : S/N : Model: 722003 30 Allura Xper FD10 722010 670 Allura Xper FD10 722011 167 Allura Xper FD10/10 722012 1951 Allura Xper FD20 722012 536 Allura Xper FD21 722012 504 Allura Xper FD22 722012 748 Allura Xper FD23 722012 536 Allura Xper FD24 722012 579 Allura Xper FD25
  • 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 Allura Xper Series: || Allura Xper FD10 || Allura Xper FD10/10 || Allura Xper FD20 || Allura Xper FD21 || Allura Xper FD22 || Allura Xper FD23 || Allura Xper FD24 || Allura Xper FD25 || 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
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