Recall Z-0264-2016 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Innokas Medical Oy
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
| Date | Nov 11, 2015 (initiated Oct 22, 2015) |
| Status | Terminated |
| Reason | Monitor may shut down unintentionally without restarting. |
| Root cause | Software design |
| Action | The firm, Innokas Medical, sent a "Urgent Field Safety Notice(s)" dated October 22, 2015 and October 23, 2015 by e-mail to their consignees. The notice informed the distributor of the device, about the deficiency, and correction of the device. The notice included the instructions regarding what to do with the product and information that the devices will be updated. The consignees were instructed to complete and return the Medical Device FSCA/Recall Return Response Acknowledgement and Receipt Form via fax to +358 8 562 3151, mail to: Innokas Medical Oy, Vihikari 10, FI-90440-Kempele, Finland |
| Quantity | 424 units (38 in US) |
| Distribution | Worldwide Distribution: US (nationwide) 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 |