FDA-Device2026-10-20Class IPROCESSING DEFECT

Ventec Life Systems VOCSN+Pro ventilator recalled for internal connector failure risk

OTHERNationwide distributionMedical devices

What this means

The internal flow transducer cable connector in some Ventec VOCSN+Pro ventilators may disconnect from the main circuit board. If this happens, the ventilator may restart unexpectedly and briefly stop delivering air to the patient.

  • If you use this ventilator, contact Ventec Life Systems immediately for inspection or replacement instructions.
  • Do not ignore any unusual restarts or alerts from your device.
  • Have a backup ventilation plan in place while your device is being serviced.
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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
325 units
Manufactured in
22002 26th Ave Se, Bothell, Washington, United States
Products
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0123-2027

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