Z-0719-2018 Class II Terminated
FDA device recall Z-0719-2018 was initiated by Medistim Asa on April 25, 2017 and is designated Class II. Reason for recall: A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening. The recall status is terminated (terminated May 3, 2024). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- April 25, 2017
- Termination Date
- May 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
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.
Distribution Pattern
Distributed to New York.
Code Information
UDI: 7070554101198 Serial#: 1170 and 1294