Philips Recalls Repaired CPAP and BiPAP Machines

Philips Recalls Repaired CPAP and BiPAP Machines

Problems with Philips devices continue as the company has recalled certain reworked CPAP and BiPAP machines. In June 2021, Philips recalled millions of machines due to toxic particles that could injure patients. These DreamStation devices were among those affected. The FDA has labeled the latest recall a Class I, its most serious type. The supposedly fixed CPAP and BiPAP devices may fail to deliver sleep apnea therapy to patients, potentially leading to injury or death.

Philips’ Replacement Efforts Fall Short

Nearly two years after the recall, many patients are still awaiting a replacement device. Although Philips claims to have shipped 2,460,000 “new replacement devices and repair kits” to consumers, the FDA announced this number is inaccurate. Philips did not clarify that this number includes devices shipped internally to their own repair facilities. Therefore, the real number of devices sent to consumers is likely much lower.

Philips Recalls Over 1,000 Repaired CPAP and BiPAP Machines

Those who have received their long-awaited Philips CPAP and BiPAP replacements have reported problems.

On February 10, 2023, Philips initiated a recall for 1,088 repaired Philips Respironics DreamStation1 devices. The CPAP and BiPAP machines, which help people keep their breathing at a regular rhythm, were distributed between December 1, 2021, and October 31, 2022. Philips recalled the devices because they were incorrectly programmed, causing machines to administer the wrong therapy or none at all. The affected product models include:

  • REP DreamStation Auto CPAP Recert
  • DreamStation Auto
  • FR REP DreamStation Auto BiPAP, DOM-RECRT
  • REP DreamStation Auto CPAP

Furthermore, there is no warning or indication that the DreamStation is not working as intended. The FDA warned that incorrect therapy may lead to respiratory or heart failure, serious injury, or death. Philips has received 43 complaints to date but, thankfully, no reported injuries or deaths.

Next Steps for Patients with Recalled Repaired CPAP and BiPAP Machines

Philips is contacting individuals with the affected DreamStation to arrange replacement and repair. For the time being, patients can determine whether their machine is subject to the recall by comparing the serial number on their machine with the one on the letter they received from Philips. Philips recommends patients continue to use the current device until a replacement device arrives or until their provider manually resets the pressure on the current device.

Philips Faces Growing Lawsuits Over Recalled CPAP and BiPAP Machines

Individuals have partnered with Philips CPAP cancer lawyers to file lawsuits against the company following the June 2021 recall. Claimants allege Philips neglected to warn the public that the soundproof foam in its products could degrade and release toxic particles or gases. If inhaled or ingested, lawsuits claim the contaminants could result in cancer or respiratory complications. Between April 2021 and April 2023, the FDA received over 98,000 medical device reports tied to recalled Philips devices, including 346 deaths.

Have you experienced cancer, respiratory issues, or other serious health problems after using a Philips CPAP machine? Contact The Lake Law Firm today at (888) 525-3529 for a free case evaluation to see if you qualify to file a claim.