⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Ventec Life Systems, Inc.: VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Medical DevicesSource: FDA (device) · Date: 2026-07-01

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Ventec Life Systems, Inc.
Product
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of UT.
Recall initiated
2026-05-08
Code info
REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613
Product quantity
1
Voluntary mandated
Voluntary: Firm initiated
City
Bothell
State
WA
Country
United States
Event id
98888
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