Ventec Life Systems, Inc. — Class II: VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Ventec Life Systems, Inc. has initiated a Class II recall for VOCSN+Pro ventilator packages and units due to damaged back-up batteries that support the backup alarm function. This damage could prevent the alarm from activating during a loss of primary power or depletion of other backup sources.
This recall affects Ventec Life Systems, Inc., clinical departments using VOCSN+Pro respiratory systems (REF: PRT-00853-000 and PRT-00490-001), and healthcare technology management staff responsible for ventilator maintenance.
The failure of a backup alarm in a life-support device represents a significant safety risk, as it may delay caregiver awareness of a ventilator failure. From a regulatory perspective, this suggests a potential deficiency in battery component quality control or durability. This situation necessitates an immediate review of risk documentation related to secondary power failures and alarm redundancy.
QA and clinical engineering teams should verify the serial numbers of on-site VOCSN+Pro units against the recall list and ensure that primary power and main battery protocols are strictly followed until damaged back-up batteries are replaced. Regulatory teams should monitor the ongoing status of this recall for potential corrective action updates from the manufacturer.
Class II. 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.. Product: VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001. Firm: Ventec Life Systems, Inc. (Bothell WA United States). Status: Ongoing.
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