BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more

FDA device recall Z-2036-2025 · posted 2025-07-02 · Open, Classified

Recall details

Recalling firm

Philips Respironics, Inc.

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

MNS

Quantity affected

3 units in US 22,416 units and 49 units OUS

Distribution

Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (B

Date initiated

2025-05-09

Date posted

2025-07-02

Location

Murrysville, PA

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