Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators
React Health is removing VOCSN V+Pro ventilators from the market due to a manufacturing process deviation that could lead to an undetected oxygen leak.
React Health, healthcare facilities using VOCSN V+Pro ventilators, and medical device manufacturing and quality personnel.
An undetected oxygen leak in a ventilator presents a significant safety risk, as it may compromise therapy delivery or create a fire hazard without alerting the operator. This suggests a failure in the manufacturing quality control process meant to ensure the integrity of the device's pneumatic path. Regulatory professionals should view this as a serious technical failure requiring thorough root cause analysis of the manufacturing deviation.
QA and Manufacturing teams should verify if internal manufacturing process controls for sealing or gas-path integrity are sufficient to catch deviations. Clinical engineering departments must identify and quarantine affected VOCSN V+Pro units immediately. Regulatory teams should monitor for follow-up Class I recall classification from the FDA.
React Health is removing affected devices due to a manufacturing process deviation that may result in an undetected oxygen leak condition.
Open in openFDA / FDA.gov