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

Class II
Recalling firm
Ventec Life Systems, Inc.
Reason for recall
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.
Affected products (lot / model / serial)
REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613
Units affected
1
Distribution pattern
US Nationwide distribution in the state of UT.
Firm location
Bothell, WA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2525-2026
Recall initiated
May 8, 2026
FDA classification date
June 23, 2026
FDA report date
July 1, 2026
FDA event ID
98888
Last updated on HTM Vibe
July 23, 2026
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