FDA Issues Most Serious Type of Recall for Philips Respironics BiPAP Ventilators — Lives at Risk Without Urgent Action

The U.S. Food and Drug Administration (FDA) has issued a Class I recall — the most serious category — for certain Philips Respironics BiPAP ventilators, warning that continued use without correction may result in serious injury or death. This action affects all lots of the BiPAP A30, A40, and V30 Auto devices.

This is not a removal from use or sale, but a correction recall — meaning the devices remain where they are used but require updated instructions to help prevent catastrophic failures during operation.

Unfortunately, the risk is not hypothetical. According to the FDA, there have been 13 reported injuries and eight confirmed deaths linked to this malfunction.

What’s Happening With These Devices?

Philips Respironics reports that these ventilators can experience critical failures in their “Ventilator Inoperative” alarm systems. Specifically, the devices may:

• Reboot unexpectedly for 5–10 seconds, pausing therapy and displaying a blank screen before resuming with the same patient settings.

• Reboot unexpectedly and resume using factory default settings, potentially delivering incorrect therapy.

• Enter a “Ventilator Inoperative” state after repeated reboots, shutting down therapy completely while sounding audible and visual alarms.

For patients dependent on these machines, such interruptions can cause hypoventilation, hypoxemia, hypercarbia, respiratory failure, or even death — particularly in medically vulnerable populations.

Affected Models

All lots of the following are included in the recall:

• BiPAP A30 (UDI: 00606959039308) – for home and clinical use in patients with OSA and respiratory insufficiency

• BiPAP A40 (UDI: 00606959039476) – for invasive and non-invasive support in home or clinical settings

• BiPAP V30 Auto (UDI: 00606959049635) – for institutional use in adults and children over 10 kg

What Patients and Caregivers Should Do

Philips Respironics issued an URGENT Medical Device Recall Notice in March 2024 instructing patients and caregivers:

1. If the ventilator inoperative alarm occurs: Remove the patient from the device immediately and connect them to an alternate source of ventilation.

2. If interruptions can be tolerated: Follow provided instructions to remove the patient from the device and arrange for an alternative machine.

3. Optional step: Attempt a “hard reboot” (forced restart), which may temporarily restore function.

4. Notify all relevant parties: Distribute the recall notice to physicians, clinicians, and patients using the affected devices.

5. Complete and return the recall response form included in the notice.

If you have questions, Philips Respironics can be reached at 1-800-345-6443 (prompt 4 then 5) or by email at respironics.clinical@philips.com.

Why This Matters

Ventilators are a lifeline for patients with respiratory conditions — many of whom cannot survive prolonged therapy interruptions. When a device designed to keep people breathing instead fails unexpectedly, the results can be immediate and irreversible.

This recall also comes at a time when Philips Respironics is already under scrutiny for prior respiratory device issues — including foam breakdown in CPAP and BiPAP machines — that affected millions of patients worldwide. Each new safety alert underscores the importance of vigilance, transparency, and accountability in medical device manufacturing.

KBD Attorneys’ Commitment to Patients and Families

At KBD Attorneys, we know that a recall like this is more than a notice on a government website — it’s a deeply personal crisis for the families relying on these machines. Our hearts go out to the loved ones of the eight people who have already died, and to the many others who may have suffered harm without realizing the connection to their ventilator’s malfunction.

If you or someone you love:

• Uses a Philips Respironics BiPAP A30, A40, or V30 Auto ventilator, and

• Has experienced unexplained respiratory distress, hospitalization, or death,

…you may have legal options.

We can investigate whether the device’s malfunction contributed to your injuries or loss, help you understand your rights, and fight to hold negligent manufacturers accountable.

Potential Legal Claims

In cases like this, possible claims may include:

• Product liability — if the design or manufacture of the ventilator made it unreasonably dangerous.

• Failure to warn — if Philips failed to provide adequate notice of risks in time to prevent harm.

• Negligence — if the company did not act reasonably to ensure the safety of its products.

Time limits (statutes of limitation) apply to filing such claims, so it’s important to seek legal advice as soon as possible.

Philips-Related Content

We have written about Philips related content before. For more information on which Philips products could result in oinjury, read our blogs.

Philips Allura and Azurion Patient Table Recall
The FDA classified this recall as its most serious type, citing risks of severe injury, including head trauma, lacerations, and in rare cases, death. While the devices remain in use, Philips issued detailed new safety procedures for mattress placement and patient transfers.

Philips Tack Endovascular System Recall
This is a Class I recall and discontinuation of its Tack Endovascular System, a vascular implant used to repair blood vessel damage after angioplasty or stenting. The recall followed reports of serious complications—including arterial blockages, perforations, dissections, and in severe cases, the need for bypass surgery or amputation—linked to “user challenges” during implantation. Twenty injuries have been reported, prompting Philips to remove affected devices from distribution and urge healthcare providers to stop using them immediately.

Philips Cardiac Telemetry Recall
It is a Class I recall—FDA’s most serious designation—after two reported fatalities tied to the device’s failure to trigger critical ECG alerts. Roughly 21,000 devices are impacted. These telemetry systems allow remote cardiac monitoring, but a software malfunction meant that urgent cardiac events could go undetected, depriving patients of timely intervention and placing them at serious risk.

Philips Outpatient Telemetry Monitoring System recall

There have been two reported deaths. The recall stems from a software issue in Philips’ mobile Monitoring Service Application that may fail to transmit ECG events properly, potentially delaying urgent medical care.

Ventilator Content

We have also written about recalled ventilators before. 

Medtronic Newport HT70 and HT70 Plus ventilator recall

This is a Class I alert issued after two serious injuries and a death. These life-sustaining devices, used in hospitals and home care, may shut down or fail to sound alarms, putting patients at risk of respiratory failure or death.

Our Message to Those Affected

Medical devices should be tools of healing, not harm. No family should face the devastating reality that the very machine meant to sustain life instead caused injury or death.

KBD Attorneys stands with patients and families across the country as they navigate the consequences of these failures. We will continue to monitor this recall closely, provide updates, and fight for justice on behalf of those harmed.

If you believe your injuries or a loved one’s death may be connected to this recall, contact us today for a free, confidential case review.