Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0719-2018

April 25, 2017

Class II

Product summary

Firm
Medistim Asa
Event
Event 78973
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-0719-2018

Official wording

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

Code information: UDI: 7070554101198 Serial#: 1170 and 1294

Distribution pattern: Distributed to New York.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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