Recall Z-1196-2025 ยท CBK Ventilator, Continuous, Facility Use
Ventec Life Systems, Inc.
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
| Date | Feb 26, 2025 (initiated Feb 3, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component change control |
| Action | On 02/03/2025, recall notices were sent to Durable Medical Equipment Distributors asking them to do the following: Clinical Action: Follow internal procedures to transfer the patient to an alternative source of ventilation, if available. If no other ventilation method is available, you may continue to use the affected product adhering to the guidelines below, while you await device correction by firm Service personnel: 1. Use only when the patient is actively monitored to ensure timely response to a potential malfunction. 2. Operate the ventilator as defined in the Instructions for Use and |
| Quantity | 30 |
| Distribution | US distribution in CA, NY, and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162877 | VOCSN Unified Respiratory System Ventec Life Systems, Inc., Apr 7, 2017 |