Device Recall Philips

  • 모델명 / 제조번호(시리얼번호)
    Software versions A.02.00 and lower
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Foreign:Canada, Austria, Australlia, Belgium, China, Denmark, Finland, France, Germany, Israel, Italy,Kuwait, Latvia, Lebannon, Libya, Netherland,Norway, Portugal, Qatar, Russia, Singapore,South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand,Tunisia, UK, United Arab Emirates, Yemen
  • 제품 설명
    Philips Heartstart MRx Monitor/Defibrillator || Models: M3535A (Hospital Use) , M3536A (EMS Use)
  • Manufacturer
  • 1 Event

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 229 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    7220063, 722064, 22065, 722066, 722078, 722079
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Distribution.
  • 제품 설명
    Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 || The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures ( such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP) Non-vascular interventions such as drainages, biopsies and vertebroplastics procedures The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    412 units affected.
  • 제품 설명
    Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
  • Manufacturer
  • 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
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