Device Recall PHILIPS Xper Flex Cardio Physiomonitoring System

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico., and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Kazakhstan, Kenya, Malaysia, Mexico, Mauritius, Netherlands, New Zealand, Pakistan, Philippines, Poland, Romania, Russian Fed, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, Utd. Arab Emir, Uzbekistan and Vietnam.
  • Product Description
    PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) || The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • Manufacturer Parent Company (2017)
  • Source
    USFDA