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Medistim Veriq System, Model Vq4122 recallZ-0719-2018 · Medistim Asa · initiated Apr 25, 2017

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medistim Asa or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0719-2018
Status
Terminated
Initiated by the company
Apr 25, 2017
Recalling firm
Medistim Asa
Quantity
2
Product code
DPW
FDA submissions
K040228
Distribution
Distributed to New York.

Product description

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

Code information (models, lots, serial numbers)

UDI: 7070554101198 Serial#: 1170 and 1294

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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