Invivo Corporation recalls Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when…

Recall date

August 18, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0263-2018

FDA classification

Class II

Brand / firm

Invivo Corporation

Sold / distributed

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, Ca…

Why it was recalled

Intermittent communication between the host system and the FlexCardio

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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