FDA-Device2026-10-20Class IPROCESSING DEFECT

Ventec Life Systems VOCSN+Pro ventilator recalled for potential interruption of ventilation therapy

OTHERNationwide distributionMedical devices

What this means

The internal flow transducer cable connector in Ventec's VOCSN+Pro ventilator may disconnect from the internal circuit board. If this occurs, the device could restart unexpectedly and temporarily stop delivering ventilation support to the patient.

  • If you use or operate a VOCSN+Pro ventilator (Model PRT-00490-001), contact Ventec Life Systems immediately for guidance.
  • Do not attempt to repair or troubleshoot the cable connection yourself.
  • Continue to monitor your device and have manual backup ventilation equipment nearby as a precaution.
  • Consult your respiratory therapist or healthcare provider about this recall and whether your specific 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
4,369 units
Manufactured in
22002 26th Ave Se, Bothell, Washington, United States
Products
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0122-2027

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