Recall Z-2604-2016— INNOKAS MEDICAL OY

Name: FDA recall Z-2604-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-27

Class II · Terminated

Class II FDA medical device recall by INNOKAS MEDICAL OY, initiated 2016-07-27, terminated 2017-04-19. It names one FDA 510(k) clearance: K133810. Product: CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.. Reason: A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements..

Recalling firm: INNOKAS MEDICAL OY
Classification: Class II
Status: Terminated
Initiated: 2016-07-27
Terminated: 2017-04-19
Firm location: KEMPELE, Finland

510(k) clearances named in this recall

1 on FDA's record

K133810 — VC150 VITAL SIGNS MONITORInnokas Yhtyma·cleared 2014-10-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.