FDA-Device2026-10-20Class IPROCESSING DEFECT

Ventec Life Systems VCSN+Pro ventilator recalled for potential loss of ventilation due to connector disconnection

ELECTRICAL SHOCKNationwide distributionMedical devices

What this means

The internal flow transducer cable connector on the Ventec VCSN+Pro ventilator may disconnect from the internal circuit board. If this happens, the device may reboot and temporarily stop delivering ventilation therapy to the patient.

  • Stop using the device immediately if you have one of the affected units (Model PRT-01184-000, Package PN PRT-01172-000).
  • Contact Ventec Life Systems or your equipment provider right away for instructions on inspection, repair, or replacement.
  • Have an alternative ventilation device or backup plan in place until your device is addressed.
  • Check your device serial number against the UDI 00855573007860 to confirm if your unit is affected.
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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
4,368 units
Manufactured in
22002 26th Ave Se, Bothell, Washington, United States
Products
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0128-2027

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