Recall Z-0719-2018— Medistim Asa
Class II · Terminated
Class II FDA medical device recall by Medistim Asa, initiated 2017-04-25, terminated 2024-05-03. It names one FDA 510(k) clearance: K040228. Product: MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.. Reason: A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening..
- Recalling firm
- Medistim Asa
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-25
- Terminated
- 2024-05-03
- Firm location
- Oslo, N/A, Norway
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
Reason for recall
A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
Data sourced from openFDA. This site is unofficial and independent of the FDA.