Cl II CARESCAPE VC150 Vital Signs Monitor

Company: Innokas Medical Oy.
Date of Enforcement Report 11/18/2015
Class lI:

PRODUCT

CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
Recall Number Z-0264-2016

REASON
Monitor may shut down unintentionally without restarting.

RECALLING FIRM/MANUFACTURER
Innokas Medical Oy. Kempele, FI on 10/22/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
756

DISTRIBUTION
Nationwide and Internationally

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