Medical device recalls Moderate risk

INNOKAS MEDICAL OY recalls CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.

Recall date
July 27, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2604-2016
FDA classification
Class II
Brand / firm
INNOKAS MEDICAL OY
Sold / distributed
AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI

Why it was recalled

A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.

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; Intended to monitor a single patient's vital signs at the site of care.

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