Recall Z-1022-2015 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
INNOKAS MEDICAL OY
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
| Date | Jan 28, 2015 (initiated Dec 3, 2014) |
| Status | Terminated |
| Reason | If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms. |
| Root cause | Software design |
| Action | A notification letter was sent to the distributors on 12/3/2014. The letter requests the devices be returned to the manufacturer for repair. |
| Quantity | 20 units |
| Distribution | Distributed in the US and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133810 | VC150 VITAL SIGNS MONITOR Innokas Yhtyma, Oct 30, 2014 |