FDA posted an early alert on September 23 covering 12 configurations of React Health's VOCSN ventilator, among them VOCSN+Pro, VC+Pro, V+Pro and V+Home. Units with serial numbers 112786 and higher are affected. The internal flow transducer cable connector can work partly or fully loose, and the device then loses communication with the transducer board.
The device reboots and throws recurring System Fault 10 alarms. Dropping the ventilator or knocking it can set the condition off. Affected units went to the US and Japan. As of August 12, React Health had reported no serious injuries or deaths.
React Health sent customers a letter on September 17 telling them to keep working backup ventilation on hand, handle the devices carefully and call the company for service. Early alerts go out before FDA classifies a recall, so the classification and whatever correction follows are still ahead. A connector that unseats after a drop is a mechanical retention problem, and design verification for a home-use ventilator is supposed to include the drop.