Ventec Life Systems Inc (dba 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, according to an FDA alert.
The FDA reports 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.
Per the FDA alert, 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, according to the FDA.
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, according to the FDA.
As of August 12, 2026, React Health has not reported any serious injuries or deaths associated with this issue, the FDA reports.
Affected Devices
| Device Name | Model Number | Packaged Part Number | UDI-DI |
|---|---|---|---|
| VOCSN+Pro | PRT-00490-001 | PRT-00853-000 | 00855573007792, 00855573007006 |
| VOCSN+Pro (Japan) | PRT-00490-100 | PRT-00853-100 | 00855573007761, 00855573007204 |
| VC+Pro | PRT-00900-001 | PRT-00973-000 | 00855573007785, 00855573007433 |
| VC+Pro (Japan) | PRT-00900-100 | PRT-00973-100 | 00855573007211 |
| VOCSN | PRT-01100-000 | PRT-01126-000 | 00855573007747 |
| VOCSN (Japan) | PRT-01100-100 | PRT-01126-100 | 00850018761130 |
| VCSN+Pro | PRT-01184-000 | PRT-01172-000 | 00855573007860 |
| V+Pro | PRT-01185-000 | PRT-01198-000, PRT-01198-010 | 00855573007877 |
| V+Pro | PRT-01185-001, PRT-01185-002 | N/A | 00850018761154, 00850018761161 |
| V+ Pro Emergency | PRT-01201-000 | PRT-01173-000 PRT-01222-000 | 00855573007945 |
| VC | PRT-01098-000 | PRT-01125-000 PRT-01125-010 | 00855573007730 |
| VC (Japan) | PRT-01098-100 | PRT-01125-100 | 00850018761116 |
| V*Home | PRT-01444-000 | PRT-01445-000, PRT-01445-010 | 00855573007822 |
FDA Recommendations
If your device exhibits this issue, use back-up ventilation as needed and contact React Health for device servicing. Patients should not discontinue therapy unless an appropriate alternative means of ventilation is available and they are instructed to do so by their treating clinician.
On September 17, React Health sent all affected customers a letter recommending the following actions:
- If your device exhibits this issue (recurring reboots/System Fault 10 alarms), utilize back-up ventilation as needed and contact React Health for device servicing.
- Patients should not discontinue therapy unless an appropriate alternative means of ventilation is available and they are instructed to do so by their treating clinician.
- Ensure that alternative ventilation equipment is not only available but is functional, regularly checked, and ready for immediate use if required.
- Ensure that the ventilator is secure during use. Place ventilator on a flat, stable surface or secure it using the VOCSN roll stand or carry bag. Keeping the ventilator secure helps prevent accidental drops or impacts that could affect device operation.
- If the device is dropped or experiences an impact, perform the Checkout Procedure in the VOCSN Series Ventilator Portfolio Clinical & Technical Manual, LBL-00001, prior to patient use to confirm device performance.
- Follow device manual recommendations, especially those related to monitoring, emergency preparedness, caregiver training, and the availability of backup ventilation equipment whenever the ventilator is being used.
- For ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device. Failure to do so may result in patient injury or death.
- Ventilator-dependent patients should be continuously monitored by qualified personnel or adequately trained carers. These personnel and carers must be capable of taking the necessary corrective action in the event of a ventilator alarm or malfunction.
- Ensure that caregivers are appropriately trained, that their training is up to date, and that they are confident in responding to alarms and emergency situations.
- Monitor patients with pulse oximetry and CO2 monitoring, if available.
- As indicated in the VOCSN Series Ventilator Portfolio Clinical & Technical Manual, LBL-00001 instructions, always use packaging approved by Ventec Life Systems when shipping devices.
- Healthcare Providers, Distributors, and/or DMEs:
- Promptly notify all affected patients and/or caregivers under your care and communicate the applicable Patient/Caregiver information and Clinical Actions provided in this notice.
- If you have distributed or transferred affected devices to other facilities, caregivers, or end users, promptly notify them of this issue and provide a copy of this notification.
More information is available on the FDA website.
