Recall Z-0719-2018
Medistim Asa · initiated April 25, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
Codes / lots: UDI: 7070554101198 Serial#: 1170 and 1294
Reason for recall
A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
FDA-determined 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.
Details
- Recall number
- Z-0719-2018
- Initiated
- April 25, 2017
- Terminated
- May 3, 2024
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Quantity
- 2
- Distribution
- Distributed to New York.
- Recalling firm
- Medistim Asa, Oslo