FDA-Device2025-03-05Class I
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Ventec Life Systems, Inc.
Hazard
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
Sold states
US distribution in CA, NY, and MO.
Affected count
30
Manufactured in
22002 26th Ave Se, N/A, Bothell, WA, United States
Products
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1196-2025Don't want to check this manually?
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