FDA-Device2026-10-20Class IPROCESSING DEFECT

Ventec Life Systems VC ventilator recalled for internal cable disconnection risk

ELECTRICAL SHOCKNationwide distributionMedical devices

What this means

The internal flow transducer cable connector in the Ventec VC ventilator (Model PRT-01098-000) may disconnect from the internal circuit board. If this happens, the ventilator may reboot unexpectedly and temporarily stop delivering ventilation therapy to the patient.

  • If you use or operate a Ventec VC ventilator, contact Ventec Life Systems immediately for instructions or a replacement.
  • Do not ignore signs of sudden device shutdown or unexpected rebooting.
  • Have a backup ventilation plan in place until this issue is resolved.
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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
930 units
Manufactured in
22002 26th Ave Se, Bothell, Washington, United States
Products
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0130-2027

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