Company: INNOKAS MEDICAL OY
Date of Enforcement Report 8/31/2016
Class lI:
PRODUCT
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient’s vital signs at the site of care.
Recall Number Z-2604-2016
REASON
A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.
RECALLING FIRM/MANUFACTURER
INNOKAS MEDICAL OY, KEMPELE , Finland on 8/19/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1458 units
DISTRIBUTION
AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI
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