Recall Z-0264-2016— Innokas Medical Oy

Name: FDA recall Z-0264-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-22

Class II · Terminated

Class II FDA medical device recall by Innokas Medical Oy, initiated 2015-10-22, terminated 2016-07-01. It names one FDA 510(k) clearance: K133810. Product: CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans. Reason: Monitor may shut down unintentionally without restarting..

Recalling firm: Innokas Medical Oy
Classification: Class II
Status: Terminated
Initiated: 2015-10-22
Terminated: 2016-07-01
Firm location: Kempele, N/A, 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 Monitor vital signs in humans

Reason for recall

Monitor may shut down unintentionally without restarting.

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