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INNOKAS MEDICAL OY recalls CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
Recalled August 31, 2016 · FDA recall Z-2604-2016 · INNOKAS MEDICAL OY
Hazard
A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements. · FDA Class II
Units
1715 units
Sold at
AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI
Description
A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.
Product
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
Manufacturer(s)
INNOKAS MEDICAL OY
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →