About 93 reworked units distributed in the United States and France may have incorrect configurations that could lead to serious health risks.

Key takeaways:

  • The recall affects approximately 93 devices, including 65 in the United States, that may have been incorrectly programmed during supplier rework tied to earlier foam remediation.
  • Impacted models include DreamStation Auto CPAP (UDSX500S11F, UFRX500S14) and DreamStation Auto BiPAP (UDSX700S11F).
  • Three injuries but no deaths have been reported in connection with the affected devices.
  • Philips advises patients to continue using devices until replacements arrive, and to follow instructions for device return once a replacement is received.

Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier. The error may result in incorrect therapy modes (for example, BiPAP configured as CPAP), limited pressure, unavailable features, or improper sensor/humidifier function.

According to a Philips Respironics spokesperson, this recall affects approximately 93 units total, or about 65 devices in the United States and 28 in France. The affected devices were reworked as part of an earlier foam-related remediation effort and may have been incorrectly configured before distribution.

The model numbers are: 

  • DreamStation Auto CPAP UDSX500S11F; Unique Device Identifier (UDI): 00606959423314
  • DreamStation Auto BiPAP UDSX700S11F; UDI: 00606959423338
  • DreamStation Auto CPAP UFRX500S14; UDI: 00606959455045

The recent customer notice is a re-issuance of a similar product notification from October 2023 to those customers who had not yet responded by phone to the prior customer outreach. “The updated notice indicates that a limited number of devices exhibited a testing error and may have been programmed with an incorrect device configuration while being remediated by a Philips supplier,” the Philips spokesperson says.

“Philips Respironics continues to send replacement devices to customers as needed, as well as recover affected units,” the spokesperson adds.

Risks of Use of Recalled BiPAPs, CPAPs

At the time of this notification, Philips Respironics has not received any reports of serious patient harm due to this issue.

However, the Food and Drug Administration (FDA) has identified this recall as the most serious type, with the devices having the potential to cuase serious injury or death. According to the FDA, there have been three reported injuries and no reports of death. Use of the affected devices may cause serious health consequences, including hypoventilation, disrupted sleep, skin or airway burns, and ineffective treatment of sleep apnea, which could worsen comorbidities.

[Related: How the Sleep Therapy Sector Is Responding to Philips Respironics’ Exit]

Philips Respironics sent affected customers an Urgent Medical Device Recall Letter recommending the following actions:

  • Continue using the device in accordance with its instructions for use and the guidance in Philips’ notice until a replacement is delivered.
  • Contact Philips at 1-877-387-3311 or [email protected] if you received the letter but have not been contacted.
  • Return affected devices using the included instructions and prepaid label when the replacement arrives.
  • Be aware that Philips is calling affected patients and suppliers and sending replacement devices with return instructions.

The spokesperson says, “Philips Respironics has intensified efforts to strengthen patient safety and quality across the company. We are methodically working through product quality at all levels and businesses in a multi-year program. We act fast on post-market surveillance signals, proactively issuing corrections, updates, or recalls when we identify potential issues.” 

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