The Philips Respironics Recall Keeps Hitting Roadblocks — The Latest Updates
When Philips Respironics announced a landmark recall of over 5 million of its devices in 2021, it caught many CPAP users by surprise. At the same time, the company promised that it would begin a process of providing its customers with replacement equipment that was free of a harmful foam defect.
The original Philips Respironics recall was issued after foam degradation and exposure to volatile organic compounds (VOCs) from sound abatement foam were reported in a wide range of the company’s devices, including many of its popular DreamStation CPAP and BiPAP machines. The sound abatement foam would often degrade, resulting in small particles that could be inhaled or ingested by a CPAP user. The recall was issued after it was determined that these issues posed a significant risk for toxic carcinogenic effects, harm to the kidneys and liver, airway inflammation, and more.
Unfortunately, Philips Respironics’ process for managing the recall has been rife with problems — and a new Class 1 recall for Philips Respironics DreamStation devices that were repaired as part of the original recall is only adding to the problems.
Some Philips Respironics Devices Are Getting ‘Re-Recalled’
The new FDA notice applies to over 1,000 DreamStation devices that had been recalled and repaired as part of the original recall notice.
As the FDA explains, “Philips is recalling certain reworked Philips DreamStations because some devices were assigned incorrect or duplicate serial numbers during initial programming. This duplication can cause therapy to be delivered using the wrong prescription or factory default settings. Additionally, it may fail to deliver any therapy at all. There is no warning or indication to the user that the DreamStation is not working the way the doctor intended or prescribed.”
The FDA has labelled this a Class 1 recall — the most serious type of recall — because therapy failure could result in heart failure, respiratory failure, and even death. To date, there have been 43 complaints connected to this new issue, though no injuries or deaths have been reported.
According to the FDA, Philips should be sending its customers a letter with a list of serial numbers that are affected by the new recall. CPAP users can check the serial number on the bottom of their device to confirm whether it needs to be repaired. As noted in the recall instructions, users can contact their medical provider to get a manual pressure reset to ensure their device is operating at the proper therapy settings.
These aren’t the first devices to get “re-recalled,” either. An FDA recall was issued in December 2022 for Trilogy 100 and Trilogy 200 ventilator devices that had been repaired as part of the original recall. In this case, silicone foam adhesion failures and exposure to debris from the foam resulted in a new Class 1 recall.
Many Customers Are Still Waiting To Receive Repair Kits
According to the Philips Respironics website, “90% of the production of replacement devices and repair kits globally has been completed.” At the same time, the website also indicates that only 2.46 million repair kits and replacement devices have been sent out within the United States. Considering that roughly 5 million machines were impacted by the recall, this indicates that a significant number of customers still have not received a replacement device.
In addition, the FDA has challenged Philips’ numbers, noting that the 2.46 million figure includes repair kits that have been shipped internally, rather than to customers, further increasing wait times for replacements.
Part of the problem is that many customers have apparently not been properly notified about the recall. CBS recently reported on a woman who claims that she only learned about the recall through Facebook, rather than ever receiving a report from the company. That woman is one of the many who have since sued Philips because of respiratory issues linked to the defective CPAP machines.
Additional Recall Fallout
As time has gone on, the details surrounding the nature of the original recall have led to increased scrutiny and pressure on Philips Respironics. Since the original recall was issued, the FDA has received over 98,000 complaints linking the devices to chest pain, cancer, pneumonia, and other respiratory problems. The agency has also received 346 reports of deaths that are claimed to be linked to the foam degradation and emissions.
Philips has also upset manufacturers of CPAP cleaning devices such as SoClean after it claimed that the foam degradation was likely the fault of ozone sanitizing devices. SoClean has also filed a lawsuit against the company under the basis that Philips tried to use it as a scapegoat for their own problems.
For those who are yet to receive a replacement of their original device, finding a safe and suitable placement should clearly be a priority.
For individuals who used (or still use) a Philips Respironics device, this entire process can be understandably stressful. If you are concerned about whether the device you use is affected by the original recall or the latest guidance from the FDA, your best course of action is to contact Philips.
For guidance related to the recall, you can use Philips Respironics’ web portal, email email@example.com, or call 1 (800) 387-3311. Their representatives can provide up to date, detailed information regarding your device.
If you or your doctor decide that your best option is to get a replacement device from another manufacturer, Help Medical Supplies can help. With CPAP machines from ResMed, 3B Medical and other leading brands available at significant discounts off of MSRP, you can get a replacement device that will help you stay compliant with your sleep apnea therapy needs.