FDA-Device2018-05-23Class II
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 technic
Invivo Corporation
Hazard
The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue.
Sold states
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.
Affected count
4375 units
Manufactured in
12151 Research Pkwy Ste 200, Orlando, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1867-2018Don't want to check this manually?
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