Philips recalls certain sleep and respiratory care devices over cancer risk

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The company said the foam in the devices could degrade into particles and enter the device’s air pathway

Philips has announced that it’s recalling some of its breathing devices and ventilators due to their risk of causing cancer in users.

The company said Monday that specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices are made with foam to soften the sound of the machines. That foam could degrade over time and become carcinogenic. 

Philips said most users didn’t notice a degradation of the foam. However, it decided to recall the products because a small number of users did.

“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 company said in a press release. “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.” 

The company said no deaths have been reported in connection with the devices. 

“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 a statement.

Talk with your doctor before stopping treatment

Consumers using the recalled devices to sustain life should talk with their physician before discontinuing use, Philips said.   

“Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable,” the company said. “In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.”

The company said it’s working with the appropriate regulatory agencies towards a resolution. That will include “the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices.” More information about the recall can be found here

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