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INNOKAS MEDICAL OY recalls VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx O
Recalled February 4, 2015 · FDA recall Z-1022-2015 · 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. · FDA Class II
Units
20 units
Sold at
Distributed in the US and Europe.
Description
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.
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.
Manufacturer(s)
INNOKAS MEDICAL OY
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →