Medical device recalls High risk

Ventec Life Systems, Inc. recalls VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF:…

Recall date
February 3, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1196-2025
FDA classification
Class I
Brand / firm
Ventec Life Systems, Inc.
Sold / distributed
US distribution in CA, NY, and MO.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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