Philips issues voluntary recall of certain CPAP devices due to cancer concerns
June 15, 2021
•Land Line Staff
Royal Philips is issuing a voluntary recall for some of its ventilators, as well as CPAP and Bi-Level PAP machines because of concerns that the sound abatement foam component of the devices might degrade and become toxic or possibly cancerous.
According to the company’s news release, the majority of the affected devices are in the first-generation DreamStation product family. The recall notification affects devices sold in the U.S. only.
“Despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam,” the release states.
The news release says those risks include that the foam “may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.”
Although the company says it has received no reports of patient impacts because of chemical emissions, the potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects.
The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone. High heat and high humidity environments may also contribute to foam degradation, according to the release.
“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” Frans van Houten, CEO of Royal Philips, said in the news release.
The recall notification advises patients and customers using affected BPAP and CPAP devices to take the following actions:
- Discontinue the use of your device and work with your physician or Durable Medical Equipment provider to determine the most appropriate options for continued treatment.
- To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.
Repair and replacement program
Philips says it will replace the current sound abatement foam with a new material and has already begun the preparations, which include obtaining the relevant regulatory clearances.
As part of the program, the first-generation DreamStation products will be modified with a different sound abatement foam and shipped upon receipt of the required regulatory clearances. The recently launched next-generation CPAP platform, DreamStation 2, is not affected by the issue. The company says it is increasing the production of the DreamStation 2 devices. LL