FDA DevicesClass II
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Published: July 1, 2026Recall ID: Z-2525-2026Category: devicesCountry: US
Reason for Recall / Hazard
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
Product Description & Identification
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Additional Source Details
| Field | Value |
|---|---|
| City | Bothell |
| State | WA |
| Event id | 98888 |
| Address 1 | 22002 26th Ave Se |
| Address 2 | N/A |
| Code info | REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613 |
| Postal code | 98021-4903 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 1 |
| Reason for recall | Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260508 |
| Initial firm notification | Letter |
| Center classification date | 20260623 |
Overview
- Recalling FirmVentec Life Systems, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of UT.