Medical device recalls Moderate risk

MEDISTIM VERIQ SYSTEM recalled over fire hazard

Recall date
April 25, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Medistim Asa recalls MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons…
Recall number
Z-0719-2018
FDA classification
Class II
Brand / firm
Medistim Asa
Sold / distributed
Distributed to New York.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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