Device Recall Philips Healthcare

  • Modèle / numéro de série
    S/N: 1181 1188 1189
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Philips Healthcare INTEGRIS vascular System || Model : 722122 || 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

Fabricant

  • Adresse du fabricant
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
  • Source
    USFDA

79 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Serial numbers ranging from: US12700465 to US20823366
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution
  • Description du dispositif
    Radiohead Access Point 1.4 GHz Radiohead Access Point || Firmware versions: C.00.04 & C.00.05 || Part Number: 989803171211 || Product Usage: || IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips IntelliVue Information Center. MX40 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network.
  • Manufacturer
  • Modèle / numéro de série
    Software versions: F.02, R.02, 9.xx or any earlier versions   Addendum Models: M3532A, M3535A, M3536AM, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 M3535A- HeartStart MRx Defibrillator Monitor M3536A- HeartStart MRx Defibrillator Monitor EtC02 Options A04 A05 A06 All M3532A Upgrade
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide and OUS.
  • Description du dispositif
    Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement || 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. The HeartStart MRx EtCO2 Option monitors carbon dioxide (CO2) and measures end-tidal carbon dioxide (EtCO2). The option provides an EtCO2 value and a CO2 waveform on the devices display.
  • Manufacturer
  • Modèle / numéro de série
    Serial numbers: US00558442 - US00558461 US00561519 US00558531 - US00558532 US00561578 US00558615 US00562454 US00558758 - US00558759 US00562504 - US00562527 US00560165 - US00560166 US00562640 - US00562641 US00560738 - US00560739 US00562832 US00560740 - US00560745 US00563125 US00560872 US00563231 - US00563243 US00560909 US00564032 US00561068 US00564177 US00561209 US00564409 US00561447 - US00561452 US00564793
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of IN, MS, TX and VA., and the countries of DENMARK, FRANCE, GERMANY, SPAIN and SWITZERLAND.
  • Description du dispositif
    Philips HeartStart MRx Monitor/Defibrillator || Models: M3536A Options A20 - A27, HeartStart MRx ALS || Monitor (Grey) || 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
  • Modèle / numéro de série
    Serial Numbers: Serial Number Range USO1100106-USO1100372 USN1100376-USN1100960 USD1100961-USD1101095 US11201095-US11201186 US21201187-US21201239 US31201240-US31201537 US41201538-US41201585 US51201586-US51201721 US61201722-US61201924 US71201925-US71202048 US81202049-US81202168 US91202169-US91202514 US01202515-US01202990 USN1202991-USN1203537 USD1203538-USD1203968 US11303969-US11303972 US21303980-US21304488 US31304489-US31305042 US41305043-US41305295 US51305296-US51305450 US61305451-US61306138 US71306139-US71306542 US81306543-US81306998 US91306999-US91307261 US01307306-US01307458
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOLIVIA BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK DOMINICAN REPUBLIC EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GABON GERMANY GREECE GUATEMALA HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN (ISLAMIC REPUBLIC OF) IRAQ IRELAND ISRAEL ITALY JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRIYA LITHUANIA MACAU MALAYSIA MALTA MAURITIUS MOROCCO MYANMAR (Burma) NAMIBIA NETHERLANDS NEW ZEALAND NORWAY OMAN PALESTINE PERU PHILIPPINES POLAND PORTUGAL,QATAR ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SENEGAL SERBIA SEYCHELLES SINGAPORE SLOVAKIA (Slovak Republic) SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VIET NAM.
  • Description du dispositif
    Philips HeartStart XL+ Defibrillator/Monitor || Model: 861290 || The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support.
  • Manufacturer
  • Modèle / numéro de série
    Serial numbers:  11327-0019-P  11315-0023-P 11315-0027-P 11315-0031-P 11315-0032-P 11315-0033-P 11315-0036-P 11315-0109-P 11315-0214-P 11315-0219-P 11315-0391-P 11322-0084-P 11322-0088-P 11327-0043-P 11327-0044-P  Or within the following range:  11335-xxxx-P to 13214-xxxx-P
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and Internationally to: ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGUIM, BOLIVIA, BRAZIL, CANADA, CHINA, COLOMBIA, CONGO, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC, KUWAIT, LATIVA, LEBANON, LIBYAN ARAB, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, MOZAMBIQUE, MYANMAR, NEPAL, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERAL, SAUDIA ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN PROVIDENCE, THAILAND, TRINIDAND AND TABAGO, TUNISIA, TURKEY, TURKMENISTANIA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, and VIETNAM.
  • Description du dispositif
    HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries || Revision J || 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
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