Medical device recalls Moderate risk

Invivo Corporation recalls Monitor for the Functional Imaging System for Magnetic Resonance Imaging System

Recall date
February 6, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1440-2020
FDA classification
Class II
Brand / firm
Invivo Corporation
Sold / distributed
U.S Distribution: AK, AL, CA, CO, FL, IL, IN, KY, MA, MI, NY, OH, OR, PA, TN, TX and WV. *** Foreign: Australia, Canada, France, United Kingdom, Italy, Japan, Netherlands, Saudi Arabia, India and Thailand.

Why it was recalled

Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.

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

What was recalled

Monitor for the Functional Imaging System for Magnetic Resonance Imaging System

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