Medical device recalls Moderate risk

Innokas Medical Oy recalls CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

Recall date
October 22, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0264-2016
FDA classification
Class II
Brand / firm
Innokas Medical Oy
Sold / distributed
Worldwide Distribution: US (nationwide) and Europe.

Why it was recalled

Monitor may shut down unintentionally without restarting.

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

What was recalled

CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

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