INNOKAS MEDICAL OY recalls VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx…

Recall date

December 3, 2014

Source

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

Recall number

Z-1022-2015

FDA classification

Class II

Brand / firm

INNOKAS MEDICAL OY

Sold / distributed

Distributed in the US and Europe.

Why it was recalled

If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.

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

What was recalled

VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.