Invivo product recalled over fire hazard

Recall date

November 20, 2017

Source

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

Official notice title

Invivo Corporation recalls Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive in…

Recall number

Z-2115-2018

FDA classification

Class II

Brand / firm

Invivo Corporation

Sold / distributed

Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great Britain and Korea.

Why it was recalled

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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 The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.