FDA-Device2017-12-27Class II

Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.

Invivo Corporation
Hazard

Intermittent communication between the host system and the FlexCardio

Sold states
AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Puerto Rico Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bulgaria, Cambodia, Canada, Cayman Island, Chile, China, Colombia, Congo, Cote D'Ivoire, Cuba, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Papua, Paraguay, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Yemen
Affected count
4,535
Manufactured in
12151 Research Pkwy Ste 200, Orlando, FL, United States
Products
Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0263-2018

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