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Recall Observatory FDA recall evidence

Device product

VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Z-2525-2026

May 08, 2026

Class II

Product summary

Firm
Ventec Life Systems, Inc.
Event
Event 98888
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-2525-2026

Official wording

Reason: 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.

Code information: REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613

Distribution pattern: US Nationwide distribution in the state of UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.