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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