Reported Feb 4, 2015 · Terminated

VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx…

Innokas Medical Oy

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: INNOKAS MEDICAL OY · TARJUSOJANTIE 12 · KEMPELE, N/A · N/A

Is this the product you have?

  • 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.
Lot codes and dates
    • SK514470022YA
    • SK514470023YA
    • SK514470024YA
    • SK514470020YA
    • SK514470021YA
    • SK514100003YA
    • SK514470019YA
    • SK514470001YA
    • SK514470017YA
    • SK514470018YA
    • SK514450021YA
    • SK514450022YA
    • SK514450019YA
    • SK514470004YA
    • SK514470005YA
    • SK514390001YA
    • SK514150002YA
    • SK514150004YA
    • SK514150005YA
    • SK514300002YA
Amount recalled
20 units

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 24, 2015 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.