Posted on September 01, 2021
Respironics PAP Safety Recall
Recently, Philips decided to voluntarily issue a recall notification to inform patients and customers of potential impacts on patient health and clinical use related to PAP devices.
- The FDA has identified the Respironics Safety Recall as a level 1 medical recall, which has potential for harm. This is more of a problem in areas where the machine is subjected to high heat and humidity (like Florida) or ozone from unauthorized cleaning devices (like the SoClean machine).
- The FDA has approved Respironics new DreamStation 2 device, which uses a different sound abatement foam, as an acceptable and safe replacement for the affected machines. As such, Respironics has started to swap out some older devices with the newer DreamStation 2 device, however there are not enough new devices available for this to happen quickly. This process is expected to take 9-12 months. Respironics has received permission from the FDA to use devices refurbished with the new, safer sound abatement foam, to replace at risk machines, as well as a process to replace the faulty foam directly at a locally trained and approved facility. We will update this web page if any local DMEs take advantage of this opportunity for our patients.
- SoClean®, and all other cleaning devices, should not be used as they’re likely damaging the machines and putting people at possible risk.
- If you’ve not been using a SoClean® or other cleaning device, the risk is probably very low, and the benefits for you may outweigh these possible risks to continue using your PAP.
- Bacterial inline filters are not medically approved for Respironics AutoPAP and AutoBIPAP devices to stop foam particulates and do not hinder any chemical emissions resulting from foam degradation. They can restrict airflow limiting the beneficial effects of PAP therapy and need to be changed frequently.
- The current recommendation from Respironics is to stop using these devices out of an abundance of caution until they can be repaired or replaced. However, we suggest you continue using your PAP machine if you feel you benefit from it. Clean your device following manufacturer’s instructions (soap and water washes at least once weekly). Your PAP machine should get recalled and fixed/replaced once the FDA approves whatever process is finalized.
- We recommend you register your device at the Philips Respironics website using the serial number on the bottom of your machine so you will receive updates directly about the recall process going forward.
- Registered patients who haven't yet received their replacement device can now go to the Philips Patient Portal and answer questions to help Respironics prioritize those with more severe OSA for earlier replacement.
Have Questions? Online Information Hub
Recent testing updates, reported by Respironics in June 2022, show:
- Prevalence of visible foam degradation (US and CA): 164 of 36,341 (0.5%) devices with self-reported no ozone use showed significant visible foam degradation.
- Impact of repeated ozone cleaning: Devices with self-reported ozone use were 14x more likely to have significant visible foam degradation than those with self-reported no ozone use: 777 of 11,309 devices (7%) showed significant visible foam degradation.
- Assessment of a sample of devices linked to reported alleged foam degradation complaints: 422 devices of the inspected 60,847 returned/used devices are linked to a reported foam degradation complaint. However, only 18 out of these 422 devices (4%) actually showed visible foam degradation.