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FDA-Device2026-07-01Class IIPROCESSING DEFECT

Ventec Life Systems VOCSN+Pro ventilator recalled for faulty backup battery alarm

Ventec Life Systems
BATTERYNationwide distribution

Ventec VOCSN+Pro ventilator recalled for backup alarm failure

Ventec Life Systems' VOCSN+Pro respiratory ventilator may have a damaged backup battery that powers the alarm system. If primary power is lost and the backup battery is depleted or absent, the backup alarm may not sound to alert caregivers of the power loss.

  • Check your VOCSN+Pro device serial number against the lot number 804613 or 807138 listed in the recall notice.
  • Verify the backup battery is functioning and fully charged before each use.
  • Contact Ventec Life Systems immediately if your unit is affected to arrange inspection or replacement.
  • Ensure a caregiver is present during operation and do not rely solely on the alarm system.
Hazard

Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.

Sold states
US Nationwide distribution in the state of UT.
Affected count
1
Manufactured in
22002 26th Ave Se, N/A, Bothell, WA, United States
Products
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2525-2026

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