Device Recall Philips Healthcare

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution including the states of IN, MS, TX and VA., and the countries of DENMARK, FRANCE, GERMANY, SPAIN and SWITZERLAND.
  • 제품 설명
    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
  • 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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