Events

Recall of Device Recall CARESCAPE VC150 Vital Signs Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by INNOKAS MEDICAL OY.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70068
  • Event Risk Class
    Class 2
  • Event Number
    Z-1022-2015
  • Event Initiated Date
    2014-12-03
  • Event Date Posted
    2015-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132205
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • Reason
    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.
  • Action
    A notification letter was sent to the distributors on 12/3/2014. The letter requests the devices be returned to the manufacturer for repair.

Device

Device Recall CARESCAPE VC150 Vital Signs Monitor
  • Model / Serial
    SK514470022YA, SK514470023YA, SK514470024YA, SK514470020YA, SK514470021YA, SK514100003YA, SK514470019YA, SK514470001YA, SK514470017YA, SK514470018YA, SK514450021YA, SK514450022YA, SK514450019YA, SK514470004YA, SK514470005YA, SK514390001YA, SK514150002YA, SK514150004YA, SK514150005YA, SK514300002YA
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the US and Europe.
  • Product Description
    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
    INNOKAS MEDICAL OY

Manufacturer

INNOKAS MEDICAL OY
  • Manufacturer Address
    INNOKAS MEDICAL OY, TARJUSOJANTIE 12, KEMPELE Finland
  • Manufacturer Parent Company (2017)
    Serres Group Oy
  • Source
    USFDA