Device Recall Philips Medical Systems

  • Modelo / Serial
    Units distributed by Philips Healthcare Inc. and shipped between September 1, 2004 and October 1, 2009.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Class II Recall -- Worldwide Distribution -- United States, Canada, Australia, Brazil, China, France, Germany, Hong Kong, Iceland, India, Indonesia, Italy, Japan, Jordan, Kenya, Libyan Arab Jamahiriya, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Saudi Arabia, Spain, Sri Lanka, Switzerland, Trinidad, Tobago, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Philips HeartStart Vehicle Wall Mount, Model M5528A || with Philips HeartStart DC Power Module, Model M5529A. || The HeartStart MRx portable external defibrillator has optional accessories which include a wall mount and a DC power module. The wall mount is intended for storage and transport of MRx devices in land based transport vehicles. The power module is an additional optional accessory intended to be connected to the wall mount as a means for charging MRx devices (batteries) when stored in the wall mount. The DC power Module is also intended for use with an extension power cable, which is exclusively intended to be used to connect the DC module directly to the MRx. Philips private labels and distributes these devices which are designed and manufactured by Laerdal Medical.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

5 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    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
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Modelo / Serial
    Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The one system was distributed in Canada. There were no government or US distribution.
  • Descripción del producto
    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
  • Modelo / Serial
    Allura Xper Software version: R8.2.0
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Modelo / Serial
    Allura Xper Software version R8.2.0
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Modelo / Serial
    Serial Numbers: 4711A00132 4725A02724 4711A00354 4725A02791 4716A00562 4725A02897 4717A00702 4725A02927 4717A00703 4725A03255 4717A00705 4732A03719 4717A00706 4732A03725 4717A00724 4732A03764 4717A00725 4732A03765 4717A00799 4732A03766 4717A00857 4732A04028 4718A00957 4732A04031 4718A01077 4732A04134 4718A01078 4732A04178 4718A01120 4732A04400 4718A01121 4732A04623 4718A01454 4732A04671 4721A01670 4732A04675 4721A01711 4732A04746 4721A01731 4732A04868 4721A01773 4732A04869 4721A01797 4732A04870 4721A01828 4732A04871 4721A01919 4732A04872 4721A01993 4732A04873 4721A01994 4732A04874 4721A01997 4732A04875 4721A02164 4732A04876 4725A02354 4732A04877 4732A04890 4732A04896
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -USA including states of CA, MA, TX, IN, MI, FL, MN, NC, MS, HI, RI, NH, and PA, and countries of Canada, Australia, Belgium, France, Germany, Ireland, Italy, Japan, Switzerland, United Arab Emirates, and The United Kingdom.
  • Descripción del producto
    Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Manufactured and Distributed by; Philips Medical Systems, Andover, MA 01810
  • Manufacturer