Official recall notice
FDA Recall: VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
- Recall date
- 2026-07-01
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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
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.
Affected products
REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613