FDADecember 3, 2014device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
innokas medical oyinnokasinnokas medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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