Device Recall Philips Medical

  • 모델명 / 제조번호(시리얼번호)
    M3001A options A01, A01C06, A01C12, and A01C18 with serial number prefix DE512 and MMS software revision C.0 or B.1 M3001A options A02, A02C06, and A02C18 with serial number prefix DE441 and DE512 and MMS software revision C.0 or B.1
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Canada, Argentina, Australia, Austria, Belgium, Brazil, Czech, Croatia, China, Denmark, Finland, France, Germany, Israel, Italy, Jordan, Kuwait, Luxemburg, Netherlands, Oman, Norway, Poland, Portugual, Poland, Russia, South Africa, Spain, Sweden, Swizerland, Turkey, UAE, Yemen, UK, Zimbabwe, Zambia, India, Indonesia, Japan, Korea, Philipines, Malaysia, Singapore, Sri Lanka, Taiwan, Vietnam, Venezuela.
  • 제품 설명
    IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. || Model: M3001A
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810-1032
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 8 건

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  • 모델명 / 제조번호(시리얼번호)
    System Serial Numbers:  0162R15403 0162A66105 0162A65401 218134 217530 209677 716334 217721 0162R16001 0162A65301 0162R15803 0162R16002 209669 0162R15504 0162R15602 0162A66104 0162R16007 0162R15802 0162R15702 0162R16003 212866 218047 0162A66005 0162R15603 0162R16004 218085 0162R15804 217296 0162A65402 0162P21004
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide distribution in the following states: AL, CA, FL, GA, HI, IL, IN, KS, LA, MA, MI, MS, NJ, NY, OH, PA, SC, VA, WI, WV, & WY.
  • 제품 설명
    FV-RF (Clinix RF Plus) || Product Usage: || A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The one system was distributed in Canada. There were no government or US distribution.
  • 제품 설명
    Brilliance iCT || Product Usage: || Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Software releases: PBL 6.5.1 1PBL 6.5.2 1PBL 7.0.x 1PBL 7.2.x
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Allura Xper Systems Models: || Allura Xper FD10 (F/C)-Biplane Fixed || Allura Xper FD10/10 (incl. OR table) || Allura Xper FD20- High resolution fixed-x ray || Allura Xper FD20/10 || Allura Xper FD20/20 || Allura CV20 || The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended for use in cardiovascular and vascular X-ray imaging applications. including diagnostic,interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral. thoracic and abdominal angiography, as well as PTCAs. stent placements, embolisations and thrombolysis. and Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and Electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Use of the Allura Xper FD Series in the OR environment is restricted; the system should only be used for minimally invasive procedures. (Endovascular)
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Allura Xper Software version: R8.2.0
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.
  • 제품 설명
    Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. || The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Allura Xper Software version R8.2.0
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.
  • 제품 설명
    Philips Medical Systems Allura Xper FD20C with software version R8.2.O || System Code: 722035. || The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
  • Manufacturer
하나 더 3 건 더