FDA recall Z-1196-2025

Ventec Life Systems, Inc. · Class I · device

Product

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

Reason for recall

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.

Distribution

US distribution in CA, NY, and MO.

Key facts

Status
Ongoing
Initiation date
2025-02-03
Report date
2025-03-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1196-2025