FDA-Device2015-02-04Class II
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.
INNOKAS MEDICAL OY
Hazard
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.
Sold states
Distributed in the US and Europe.
Affected count
20 units
Manufactured in
TARJUSOJANTIE 12, N/A, KEMPELE, N/A, Finland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1022-2015Don't want to check this manually?
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