Events

Recall of VeriQ System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medistim Asa.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78973
  • Event Risk Class
    Class 2
  • Event Number
    Z-0719-2018
  • Event Initiated Date
    2017-04-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160991
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Flowmeter, blood, cardiovascular - Product Code DPW
  • Reason
    A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
  • 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.

Device

VeriQ System
  • Model / Serial
    UDI: 7070554101198 Serial#: 1170 and 1294
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Manufacturer
    Medistim Asa

Manufacturer

Medistim Asa
  • Manufacturer Address
    Medistim Asa, Okernveien 94, Oslo Norway
  • Manufacturer Parent Company (2017)
    Medistim ASA
  • Source
    USFDA