Ventec Life Systems, Inc.: Device Recall
Recall #Z-1196-2025 · 02/03/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-1196-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Ventec Life Systems, Inc.
- Status
- Ongoing
- Date Initiated
- 02/03/2025
- Location
- Bothell, WA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
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.
Product Description
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
Distribution Pattern
US distribution in CA, NY, and MO.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.