FDA issues early alert on React Health VOCSN ventilators over connector fault

The FDA's Center for Devices and Radiological Health has posted an early alert about a potential high‑risk problem with certain VOCSN ventilator units made by Ventec Life Systems, operating as React Health.

The issue involves the IFT cable connector becoming unseated, which can interrupt communication with the internal flow transducer board, trigger reboots and generate System Fault 10 alarms. The alert applies to devices with serial numbers 112786 and higher across multiple VOCSN models listed by the manufacturer.

React Health has sent a letter to customers advising them to follow updated usage instructions and to inspect the connectors on the affected units. Users are instructed to employ backup ventilation if the problem occurs and to contact the company for servicing. Patients should continue therapy unless otherwise directed by a healthcare professional.