FDA-Device2026-10-20Class IPROCESSING DEFECT

Ventec Life Systems VOCSN ventilator recalled for flow sensor cable disconnection risk

ELECTRICAL SHOCKOTHERNationwide distributionMedical devices

What this means

The internal flow transducer cable connector in certain Ventec VOCSN ventilators may disconnect from the internal circuit board. If this happens, the device could restart unexpectedly and temporarily stop delivering ventilation therapy to the patient.

  • If you use a Ventec VOCSN ventilator (Model PRT-01100-100), contact Ventec Life Systems immediately for guidance
  • Do not ignore unexpected device restarts or therapy interruptions
  • Have a backup manual ventilation plan in place while awaiting instructions from the manufacturer
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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
100 units
Manufactured in
22002 26th Ave Se, Bothell, Washington, United States
Products
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0127-2027

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