The Recall Desk
SevereFDA (Devices)·Z-0719-2018·Announced 2018-03-07

Medistim Veriq System Recalled Due to Component Overheating and Smoke Emission

Medistim Asa is recalling two Medistim Veriq System units because a component overheated, causing connector melting and smoke emission.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device where a component overheated, causing melting and smoke emission. This presents a significant risk of injury or property damage, aligning with the 'Severe' criteria for significant injury/property-damage reports or structural defects.

Plain-English summary

Medistim Asa is recalling two units of the Medistim Veriq System, Model VQ4122. This intraoperative diagnostic system uses ultrasonography to guide surgeons during surgical interventions. The recall is limited to two specific units identified by serial numbers 1170 and 1294, with UDI 7070554101198.

The recall was initiated because a system component overheated, which caused the connector to melt and smoke to be emitted through the system's loudspeaker opening. The affected units were distributed to New York.

Healthcare facilities and users should check their inventory for the specific serial numbers listed in the recall notice. If the affected units are found, they should be removed from service and contact Medistim Asa for further instructions.

The recalled product

Product
MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
Manufacturer
Medistim Asa
Category
Medical Device — Intraoperative Diagnostic System
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI: 7070554101198 Serial#: 1170 and 1294

Distribution

Distributed in 1 state:

Related recalls

Same manufacturer · Medistim Asa

See all →

Same hazard · overheating

See all →