MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
FDA Recall Z-0719-2018 · Posted None
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Recalling FirmMedistim Asa
Recall StatusTerminated
Product CodeDPW
Date Initiated2017-04-25
Date Terminated2024-05-03
Product Quantity2
Reason for Recall
A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed to New York.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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