Recall Z-2604-2016 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
INNOKAS MEDICAL OY
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
| Date | Aug 19, 2016 (initiated Jul 27, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Innokas Medical has notified the one US distributor on 7/27/16 via letter of the deficiency and correction of the device. |
| Quantity | 1715 units |
| Distribution | AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133810 | VC150 VITAL SIGNS MONITOR Innokas Yhtyma, Oct 30, 2014 |