FDA DevicesClass I
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Published: May 13, 2026Recall ID: Z-1942-2026Category: devicesCountry: US
Reason for Recall / Hazard
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
Product Description & Identification
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Additional Source Details
| Field | Value |
|---|---|
| City | Bothell |
| State | WA |
| Event id | 98554 |
| Address 1 | 22002 26th Ave Se |
| Code info | UDI-DI (REF/UDI-DI): PRT-01198-000/00855573007914, PRT-01185-000/00855573007877 Package/Device Serial Number (package serial number may include a "P" at the end): 152884, 152885, 152886, 152887, 152888, 152889, 152890, 152891, 152892, 152893, 152895, 152896, 152897, 152898, 152899, 152900, 152901, 152902, 152903, 152904, 152908, 152909, 152910, 152911, 152912, 152913, 152914, 152915, 152916, 152917, 152918, 152919, 152986, 152987, 155236, 156507, 156512, 156515, 156516, 156517, 156524, 156532 |
| Postal code | 98021-4903 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 42 |
| Reason for recall | 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260325 |
| Center classification date | 20260501 |
Overview
- Recalling FirmVentec Life Systems, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionUS: OH, GA, CA, MO