Z-0719-2018Class II

MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to...

Name: Z-0719-2018 MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to...
Creator: Medistim Asa
Published: 2017-04-25
License: https://open.fda.gov/license/

Medistim ASA / initiated 2017-04-25 / Terminated / root cause: manufacturing process

FDA source

Medistim Asa began a recall of MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish... on 2017-04-25. FDA classified it as Class II and gives the reason as "A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0719-2018
Classification: Class II
Status: Terminated
Initiated: 2017-04-25
Posted: 2018-02-26
Terminated: 2024-05-03
Recalling firm: Medistim ASA
Product: MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
Product code: DPW Flowmeter, Blood, Cardiovascular
Reason for recall: A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: UDI: 7070554101198 Serial#: 1170 and 1294

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0719-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0719-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-26

Product code DPW

K040228Class IIMedi-Stim Veriq System, Model Vq1001 - Vq4122Medi-Stim A/S / cleared 2004-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)