Royal Philips has recalled specific sleep and respiratory care devices due to the potential health risks related to the polyester-based polyurethane or PE-PUR sound abatement foam component.
The affected products include Bi-Level Positive Airway Pressure or Bi-Level PAP, Continuous Positive Airway Pressure or CPAP, and mechanical ventilator devices.
The recall was issued only to the Unites States customers in consultation with regulatory agencies to mitigate the risks related to the PE-PUR sound abatement foam component in these devices. For the rest of the world, the company has given a field safety notice.
Further, Philips backed its fiscal 2021 comparable sales growth and Adjusted EBITA margin guidance. According to the firm, the expected revenue headwinds in the Sleep & Respiratory Care business in 2021 will be compensated by other businesses.
The company said it has produced millions of Bi-Level PAP, CPAP and mechanical ventilator devices to date using the PE-PUR sound abatement foam.
The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family.
The complaint rate was 0.03 percent in 2020. Based on testing, the company determined that there are possible risks to users related to this type of foam. The risks include that the PE-PUR 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.
Philips noted that the foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.
With the recall, the company aims to inform patients and customers of potential impacts on patient health and clinical use related to the issue, as well as instructions on actions to be taken.
Patients using affected BiLevel PAP and CPAP devices are urged to discontinue use of device and work with physician or Durable Medical Equipment provider to determine the most appropriate options for continued treatment.
Further, patients using affected life-sustaining mechanical ventilator devices are asked not to stop or alter prescribed therapy until being talked to physician. The benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.
The company announced corrective actions including the deployment of updated instructions for use and a repair and replacement program for affected devices.
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