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Innokas Medical Oy

Country not established FDA establishment FEI 3007615597

Devices
0
Registrations
FDA
FDA recalls
3

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
3007615597
Address
Vihikari 10, KEMPELE Pohjois-Pohjanmaa

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2016

    • 27 Jul 2016 Z-2604-2016 Class II Terminated A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements. Distribution: AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI Submission number: K133810

  • 2015

    • 22 Oct 2015 Z-0264-2016 Class II Terminated Monitor may shut down unintentionally without restarting. Distribution: Worldwide Distribution: US (nationwide) and Europe. Submission number: K133810

  • 2014

    • 3 Dec 2014 Z-1022-2015 Class II Terminated 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. Distribution: Distributed in the US and Europe. Submission number: K133810

This is an FDA establishment record without devices in deviCERTS.