Device Recall Philips Healthcare

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 1 Event

제조사

  • 제조사 주소
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 79 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Code 728306, SN# 100776, UDI: (01)00884838059474(21)100776; 100778, UDI: (01)00884838059474(21)100778; 100779, UDI: (01)00884838059474(21)100779; 100780, UDI: (01)00884838059474(21)100780; 100781, UDI: (01)00884838059474(21)100781; 100782, UDI: (01)00884838059474(21)100782; 100783, UDI: (01)00884838059474(21)100783; 100784, UDI: (01)00884838059474(21)100784; 100785, UDI: (01)00884838059474(21)100785; 100787, UDI: (01)00884838059474(21)100787; 100790, UDI: (01)00884838059474(21)100790; 100791, UDI: (01)00884838059474(21)100791; and  100794, UDI: (01)00884838059474(21)1007.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
  • 제품 설명
    Brilliance iCT || Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Brilliance iCT - 728306 Devices manufactured 03/05/2009 to present.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
  • 제품 설명
    Philips Healthcare Brilliance iCT computed tomography x-ray system
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Brilliance iCT SP - 728311  Devices manufactured 03/05/2009 to present.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
  • 제품 설명
    Philips Healthcare Brilliance iCT SP computed tomography x-ray system
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    IQon Spectral CT 728332  Devices manufactured 03/05/2009 to present.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
  • 제품 설명
    Philips Healthcare IQon Spectral CT computed tomography x-ray system
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Code 728231, SN # 10655
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
  • 제품 설명
    Brilliance 64, (Code 728231) || Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • Manufacturer
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