FDA-Device2026-10-20Class IPROCESSING DEFECT
Ventec Life Systems VOCSN ventilator recalled for potential ventilation interruption
What this means
The VOCSN ventilator's internal flow sensor cable connector may disconnect from the device's internal board. If this happens, the ventilator may restart unexpectedly and temporarily stop delivering breathing support.
- Contact Ventec Life Systems immediately if you own or operate a VOCSN ventilator (Model PRT-01100-000)
- Do not rely solely on this device until you receive further guidance from the manufacturer
- Have a backup ventilation plan in place and consult your clinician right away
The agency's original wording
Hazard
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distribution US nationwide including Puerto Rico.
Affected count
1,532 units
Manufactured in
22002 26th Ave Se, Bothell, Washington, United States
Products
VOCSN
Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0126-2027More Ventec Life Systems recalls
- FDA-Device2026-10-20Ventec Life Systems V+ Pro Emergency ventilator recalled for potential breathing interruption
- FDA-Device2026-10-20Ventec Life Systems VCSN+Pro ventilator recalled for potential loss of ventilation due to connector disconnection
- FDA-Device2026-10-20Ventec Life Systems VC ventilator recalled for internal cable disconnection risk
- FDA-Device2026-10-20Ventec Life Systems VOCSN+Pro ventilator recalled for potential interruption of ventilation therapy
- FDA-Device2026-10-20Ventec Life Systems VOCSN+Pro ventilator recalled for internal connector failure risk
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