Philips Respironics has announced the recall of certain DreamStation Auto CPAP and Auto BiPAP devices due to programming errors that could compromise patient safety. Clinical and regulatory teams should take immediate note of this action, as the affected devices may lead to serious health consequences.
What changed?
On June 6, 2025, Philips Respironics issued an Urgent Medical Device Recall Letter to inform users of a programming error that arose during supplier rework in connection with an earlier foam-related remediation. This error affects therapy modes, potentially resulting in devices configured incorrectly (e.g., BiPAP being set as CPAP), pressure limitations, feature unavailability, or improper sensor/humidifier function. The FDA has classified this recall as the most serious type, emphasizing that continued use of these devices may result in severe injury or even fatal consequences.
Who is affected?
The recall concerns DreamStation Auto CPAP and Auto BiPAP devices that were distributed following the foam-related remediation, affecting patients who rely on these non-continuous ventilators for the nightly treatment of obstructive sleep apnea, both in domestic and clinical settings. As of now, three injuries have been reported, though no fatalities have been documented.
What are the health risks?
The compromised functionality of these devices poses significant risks, including hypoventilation, disrupted sleep, ineffective treatment for sleep apnea, and skin or airway burns. For patients with existing comorbidities, the risks are particularly alarming as untreated sleep apnea may exacerbate these conditions.
Instructions for affected users
Philips Respironics has outlined the following steps for affected customers:
- Continue using the device until a replacement is delivered.
- Contact Philips Respironics at PatientSupport@philips.com or call 1-877-387-3311 if you received a recall letter but have not been contacted.
- Upon receiving a replacement device, return the affected unit using the prepaid label included with the replacement.
Philips Respironics is proactively reaching out to affected users and distributors to expedite the replacement process.
How to report problems
Health care professionals and consumers experiencing adverse reactions or quality issues related to these devices are encouraged to report the events through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. The unique device identifier (UDI) system can aid in accurately identifying devices and contributing to quicker problem resolutions. Visit FDA resources for reporting tools and device identification guidelines.
Additional Resources
Patient safety and next steps
Regulatory and clinical teams should prioritize patient communication efforts to mitigate risks associated with the continued use of the affected devices. Ensuring compliance with Philips’ return and replacement instructions is essential for maintaining device performance and patient safety.
Disclaimer
This post is intended for informational purposes for professionals. It does not constitute legal advice. Always refer to official FDA communications for authoritative guidance.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/ventilator-recall-philips-respironics-removes-certain-dreamstation-devices-due-programming-errors