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A cable inside React Health's VOCSN ventilators, machines used in homes as well as hospitals, can work loose after a hard knock such as a drop and make the machine reboot; the FDA's September 23 early alert covers every unit with serial number 112786 or higher, and the company's September 17 letter says to keep backup ventilation ready and run a checkout procedure after any drop.

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The Food and Drug Administration issued an early alert on September 23 for React Health's VOCSN ventilators, which are used at home as well as in hospitals and in transport, for patients from children to adults weighing at least 5 kg. A cable inside the machine can come partly or fully unseated, and a hard knock such as a drop can cause it; the ventilator can then reboot and show recurring System Fault 10 alarms. A reboot during use would interrupt ventilation. The alert covers every VOCSN-series machine with serial number 112786 or higher. React Health's September 17 letter to customers says to keep backup ventilation working and ready, keep the machine on a flat, stable surface or in its roll stand or carry bag, run the manual's Checkout Procedure after any drop or impact, and not stop therapy without an alternative and a clinician's instruction. The company says no reboots during therapy have been reported and calls that risk remote; as of August 12, 2026, it had reported no serious injuries or deaths. Questions go to React Health at 844-698-6276.

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React Health's VOCSN ventilators help children and adults breathe in hospitals, in transport and at home, where the person who answers the alarm may be a trained caregiver. On September 23 the Food and Drug Administration passed on the maker's warning: a cable inside these machines can work loose, a hard knock such as a drop can do it, and the ventilator can then restart itself.

If that restart came while someone was on the machine, it would alarm and its breathing support would be interrupted. The alert says: "Patients who are unable to sustain adequate spontaneous ventilation are particularly vulnerable".

What goes wrong

The part is the internal flow transducer cable. If its connector comes partly or fully unseated, the machine loses contact with the board that reads air flow. The sign is a ventilator that reboots again and again, with "System Fault 10" alarms.

The alert covers every VOCSN-series machine with serial number 112786 or higher: the VOCSN, VOCSN+Pro, VC, VC+Pro, VCSN+Pro, V+Pro, V+ Pro Emergency and V*Home, plus Japan versions of several. Every model uses the same cable, whatever therapies it is set up to deliver.

Two readings on one page

The alert's explanation opens with what React Health, the trade name of Ventec Life Systems, stated. In that account no reboot has been reported during therapy, and the chance of one during active ventilation "is considered remote". The FDA's own words are different: it issued the alert to flag "a potentially high-risk device issue", the bar it sets for every early alert, and says it is "currently reviewing information".

The safety count is older than the alert: as of August 12, 2026, the company had reported no serious injuries or deaths linked to the issue.

For all of these machines, the FDA says, the letter recommends "updated use instructions and inspection procedures". The alert describes no repair for a machine working normally; servicing is for one showing the problem.

What to do at home

First check the serial number: 112786 or higher is covered. Then the main steps in the September 17 letter, as the FDA lists them:

  • Keep backup ventilation ready, such as a backup ventilator or a manual resuscitator, the hand-squeezed bag, and make sure it "is not only available but is functional, regularly checked, and ready for immediate use if required."
  • Keep the machine from falling. Set it on a flat, stable surface, or secure it in the VOCSN roll stand or carry bag.
  • After any drop or knock, run the Checkout Procedure in the VOCSN Series Ventilator Portfolio Clinical & Technical Manual, LBL-00001, before using the machine on the patient again.
  • If it keeps rebooting or showing System Fault 10, switch to backup ventilation as needed and call React Health for servicing.
  • Watch the patient. Someone trained should monitor a ventilator-dependent patient continuously, with pulse oximetry and CO2 monitoring if available.
  • Shipping it? Use packaging approved by Ventec Life Systems.

Above all:

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.

The letter also asks health care providers, distributors and medical equipment suppliers to notify patients and caregivers promptly, so the news may come through them. Questions go to React Health at 844-698-6276. Problems can be reported to FDA MedWatch.

What the record does not say

  • How many machines are affected, or how many reboots have been reported.
  • Where the serial number is printed on the machine.
  • What the Checkout Procedure involves. It is in the manual, which Hugin did not read.
  • Whether a permanent fix is coming for the connector.
  • Anything about injuries after August 12, 2026.
  • Whether this becomes a formal recall. The FDA can issue an early alert before deciding that an action meets the regulatory definition of one.
  • The letter itself. Hugin did not read React Health's September 17 letter, only the FDA's account of it.

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