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.
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. Distribution: US Nationwide distribution in the state of UT. Quantity: 1 Lot/code info: REF/UDI-DI/Serial Number/Lot: PRT-00853-000/00855573007839/155391P/807138, PRT-00490-001/00855573007792/155391/804613
00855573007839, 00855573007792
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.