FDA Medical Device Recalls (openFDA)
Medistim Asa: MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
- Recall number
- Z-0719-2018
- Recalling firm
- Medistim Asa
- Product
- MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
- Status
- Terminated
- Initiated
- 2017-04-25
- Posted
- not on file
- Terminated
- 2024-05-03
- Reason
- A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 2
- Distribution
- Distributed to New York.
- Lot, serial or model codes
- UDI: 7070554101198 Serial#: 1170 and 1294
- 510(k) numbers
- ["K040228"]
- PMA numbers
- not on file
- Product code
- DPW
- Firm FEI
- 3010790133
- Firm city
- Oslo
- Firm state
- not on file
- Firm country
- Norway
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28