Philips Respironics, Inc. BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg. Recall

Check Your Product

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

Reason for Recall

As stated by FDA

This device does not indicate for use in patients with respiratory failure.

Recommended Action

Per FDA guidance

Philips sent an "URGENT Medical Device Recall Notice", for All BiPAP A30 and BiPAP A40 devices, to consignees via mail 5/9/2025. Note, the letter does not address BiPAP V30 devices. The Notice informs consignees that for patients who cannot tolerate interruption or loss of therapy an alternative ventilator is required. Philips Respironics recommends that physicians and healthcare professionals assess whether the patients under their care who are using affected devices are able to tolerate interruptions to therapy. For patients who can and cannot tolerate interruptions in therapy, Philips Respironics provides recommendations for the clinicians and patients to consider. Patients who cannot tolerate interruptions in therapy are directed to contact their physician to expedite transition to an alternative ventilator. If a Ventilator Inoperative alarm occurs and an alternative is not available, follow Appendix A3 on how to perform a hard reboot. Consignees with any questions are to call 1-800-345-6443, prompts 4/5 or email respironics.clinical@philips.com. An additional communication was sent to consignees on 9/12/25 with further guidance for users.