FDA-Device2026-10-20Class IPROCESSING DEFECT

Ventec Life Systems VC(Japan) ventilator recalled for cable connector disconnection risk

ELECTRICAL SHOCKNationwide distributionMedical devices

What this means

The internal flow transducer cable connector in certain Ventec VC(Japan) ventilators may disconnect from the internal board. This disconnection could cause the ventilator to restart unexpectedly and temporarily stop delivering air to the patient.

  • If you use this ventilator model, contact Ventec Life Systems immediately to report your serial number and arrange inspection or replacement.
  • Do not ignore signs of unexpected restarts or ventilation interruptions.
  • Continue monitoring your device closely during use until a solution is provided.
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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
180 units
Manufactured in
22002 26th Ave Se, Bothell, Washington, United States
Products
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0131-2027

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