Company: INNOKAS MEDICAL OY.
Date of Enforcement Report 2/4/2015
Class lI:
PRODUCT
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.
Recall Number Z-1022-2015
REASON
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.
RECALLING FIRM/MANUFACTURER
INNOKAS MEDICAL OY, KEMPELE, FL 12/3/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
20
DISTRIBUTION
Nationwide and Europe
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