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U.S. Department of Health and Human Services

Class 2 Device Recall VeriQ System

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  Class 2 Device Recall VeriQ System see related information
Date Initiated by Firm April 25, 2017
Create Date February 26, 2018
Recall Status1 Completed
Recall Number Z-0719-2018
Recall Event ID 78973
510(K)Number K040228  
Product Classification Flowmeter, blood, cardiovascular - Product Code DPW
Product MEDISTIM VERIQ SYSTEM, MODEL VQ4122

An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
Code Information UDI: 7070554101198 Serial#: 1170 and 1294
Recalling Firm/
Manufacturer		 Medistim Asa
Okernveien 94
Oslo Norway
For Additional Information Contact Mike Farbelow
763-208-2089 Ext. 852
Manufacturer Reason
for Recall		 A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 2
Distribution Distributed to New York.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DPW and Original Applicant = MEDI-STIM A/S
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