CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
Medistim Veriq System recalled by Medistim A
Medistim A is recalling Medistim Veriq System, distributed in New York. The recall was initiated on 25 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0719-2018
- FDA event ID
- 78973
- Recalling firm
- Medistim A, Oslo, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2017
- FDA classified
- 26 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 25 Apr 2017 | Recall initiated by company | |
| 26 Feb 2018 | Classified by FDA | +307 days |
| 7 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
Product as listed by the FDA
MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
Where it was distributed
Distributed to New York.
Questions about this recall
Is Medistim Veriq System recalled?
Yes. Medistim A recalled Medistim Veriq System on 25 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-0719-2018.
Why was it recalled?
A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
Which lots are affected?
UDI: 7070554101198 Serial#: 1170 and 1294
Where was it sold?
Distributed to New York.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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