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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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:
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