Z-0719-2018 Class II Terminated

Recalled by Medistim Asa — Oslo, N/A

Recall Details

Product Type
Devices
Report Date
March 7, 2018
Initiation Date
April 25, 2017
Termination Date
May 3, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

Reason for Recall

A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.

Distribution Pattern

Distributed to New York.

Code Information

UDI: 7070554101198 Serial#: 1170 and 1294