MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
This recall has been terminated (originally issued April 25, 2017).
- Company
- Medistim Asa Okernveien
- Recall Initiated
- April 25, 2017
- Terminated
- May 3, 2024
- Recall Number
- Z-0719-2018
- Quantity
- 2
- Official Source
- View on FDA website ↗
Reason for Recall
A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
Distribution
Distributed to New York.
Lot / Code Info
UDI: 7070554101198 Serial#: 1170 and 1294
Root Cause
Nonconforming Material/Component
Action Taken
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.