Reported Aug 31, 2016 · Terminated

CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.

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

Is this the product you have?

  • CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
Lot codes and dates
  • 1,715 of 1,715 codes

    • SK514130002YA
    • SK514130016YA
    • SK514150001YA
    • SK514150017YA
    • SK514150020YA
    • SK514150021YA
    • SK514150022YA
    • SK514150032YA
    • SK514450012YA
    • SK514470018YA
    • SK514490005YA
    • SK514490006YA
    • SK514490009YA
    • SK514490010YA
    • SK514490011YA
    • SK514490012YA
    • SK515040001YA
    • SK515050016YA
    • SK515050017YA
    • SK515050018YA
    • SK515050019YA
    • SK515050020YA
    • SK515050021YA
    • SK515050022YA
    • SK515050023YA
    • SK515050024YA
    • SK515050025YA
    • SK515060001YA
    • SK515060002YA
    • SK515060003YA
    • SK515060005YA
    • SK515100057YA
    • SK515100065YA
    • SK515100066YA
    • SK515100068YA
    • SK515110063YA
    • SK515110066YA
    • SK515110073YA
    • SK515110118YA
    • SK515110174YA
    • SK515110183YA
    • SK515110184YA
    • SK515110185YA
    • SK515110186YA
    • SK515110187YA
    • SK515110188YA
    • SK515110189YA
    • SK515110190YA
    • SK515110192YA
    • SK515110193YA
    • SK515110195YA
    • SK515120002YA
    • SK515120003YA
    • SK515120004YA
    • SK515120007YA
    • SK515120008YA
    • SK515120012YA
    • SK515120015YA
    • SK515120017YA
    • SK515120018YA
Amount recalled
1715 units

Where it was sold

Why it was recalled

A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.

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 19, 2017 · Data as of Sep 19, 6:01 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.