Recall Z-1942-2026 ยท NOU Continuous, Ventilator, Home Use
Ventec Life Systems, Inc.
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
| Date | May 1, 2026 (initiated Mar 25, 2026) |
| Status | Open, Classified |
| Reason | Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk |
| Root cause | Process change control |
| Action | On 3/25/2026 recall notices were mailed to customers who were asked to do the following: 1. Immediately discontinue use of affected devices. 2. Inspect current stock, quarantine/segregate any unused affected products, remove affected devices from clinical service and segregate to prevent further use. 3. Use a non-affected ventilator for patient support. 4. If you have distributed or transferred affected devices to other facilities, caregivers, or end users, you must promptly notify them of this recall and provide a copy of this notification. 5. Complete and return the response form via email |
| Quantity | 42 |
| Distribution | US: OH, GA, CA, 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 |