FDA-Device2015-11-18Class II

CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

Innokas Medical Oy
Hazard

Monitor may shut down unintentionally without restarting.

Sold states
Worldwide Distribution: US (nationwide) and Europe.
Affected count
424 units (38 in US)
Manufactured in
Vihikari 10, N/A, Kempele, N/A, Finland
Products
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0264-2016

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