VOCSN Ventilators (Ventec) – servicing part issue (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.

Recommended Action

Per FDA guidance

On 02/03/2025, recall notices were sent to Durable Medical Equipment Distributors asking them to do the following: Clinical Action: Follow internal procedures to transfer the patient to an alternative source of ventilation, if available. If no other ventilation method is available, you may continue to use the affected product adhering to the guidelines below, while you await device correction by firm Service personnel: 1. Use only when the patient is actively monitored to ensure timely response to a potential malfunction. 2. Operate the ventilator as defined in the Instructions for Use and promptly respond to all alarms activated by the ventilator. 3. Use external monitors (e.g. SpO2) and set the alarm thresholds appropriately for the patient. 4. Connect the ventilator to an external monitoring system, wherever possible. Also, Durable Medical Equipment Distributors are asked to acknowledge they forwarded the recall notice, and that they contacted the users to which the devices were provided, advised them of the recall and action instructions within accompanying Recall Notification Letter including how to have the devices repaired. Complete and return the acknowledgement form via email to Ventec-Recall@reacthealth.com For any questions contact the firm at at 844-MYVOCSN (844-698-6276), Monday through Friday between 8:00 a.m. - 5:00 p.m. PDT.

Distribution

As reported by FDA

CA, IN, MO, NY