Recall Z-0719-2018 ยท DPW Flowmeter, Blood, Cardiovascular
Medistim Asa
MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
| Date | Apr 25, 2017 |
| Status | Terminated |
| Reason | A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening. |
| Root cause | Nonconforming Material/Component |
| Action | A letter was sent describing the device, reason for the recall, and risk involved. The firm stated that it would ship a VeriQ replacement system without the affected connector being used. |
| Quantity | 2 |
| Distribution | Distributed to New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040228 | MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 Medi-Stim A/S, Apr 29, 2004 |