Recall Z-2525-2026 ยท CBK Ventilator, Continuous, Facility Use
Ventec Life Systems, Inc.
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
| Date | Jun 23, 2026 (initiated May 8, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Vendor change control |
| Action | On 5/8/2026, 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 an unaffected 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) Confirm receipt of this notification letter by re |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the state of UT. |
| 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 |