Early Alert: Ventilator Issue from React Health

The FDA is aware that Ventec Life Systems Inc., doing business as React Health, has issued a letter to affected customers recommending updated use instructions and inspection procedures for all VOCSN ventilator devices with serial numbers 112786 and higher.  

React Health stated that the internal flow transducer (IFT) cable connector on VOCSN ventilator devices may become partially or fully unseated and result in loss of communication with the internal flow transducer board. This condition can lead to device reboots and recurring System Fault 10 alarms.  

This issue affects all VOCSN device configurations. The affected internal flow transducer cable is used across all device models identified in this communication, regardless of the enabled therapy configuration. No instances of reboots occurring while a patient was receiving ventilation therapy have been reported. Based on the available complaint and investigation data, the probability of an IFT-related reboot occurring while the device is actively providing ventilation therapy is considered remote. 

If a reboot were to occur while a patient is receiving ventilation therapy, the device will alarm (such as System Fault 10) and ventilation therapy from the affected VOCSN device will be interrupted. A therapy interruption could result in delay of therapy and/or a serious adverse event (depending on the patient's condition). Patients who are unable to sustain adequate spontaneous ventilation are particularly vulnerable; any interruption in therapy without the prompt initiation of alternative ventilatory support significantly increases the risk of serious injury, permanent impairment, or death, and may require immediate medical intervention to prevent irreversible harm. 

As of August 12, 2026, React Health has not reported any serious injuries or deaths associated with this issue.