FDA recall Z-0719-2018

Product

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

Distributed to New York.

Key facts

Status

Terminated

Initiation date

2017-04-25

Report date

2018-03-07

Termination date

2024-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oslo, N/A, Norway

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0719-2018