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Philips recalls breathing machines, ventilators, citing potential cancer-causing object

India Today logo India Today 15-06-2021 Milan Sharma
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The Dutch medical company Philips, one of the largest manufacturers of sleep apnea machines and ventilators, will recall between three-four million machines because of a foam part that might degrade and become toxic, potentially causing cancer.

Foam, used to dampen the machines' sound, can degrade and emit small particles that irritate airways, the group said as it announced the recall. Gases released by the degrading foam may also be toxic or carry cancer risks.

Most machines being recalled from USA

As per the company, the majority of the supplies in the USA are being recalled at the moment as 2/3 of Philips CPAP machine sales are in the USA only. The recall affects three million to four million machines, more than half of which are in the U.S. The company says that they received some complaints about the devices, representing 0.03 per cent of those sold in 2020.

The company has released this particular series of devices, which they are recalling from the market, for repair/replacement. India Today has reached out to the Philips company in an email to know if the recall will also impact India. This article will be updated once a response comes from them.

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Company spokesman Steve Klink said about 80% of the affected devices were machines used to help people with sleep apnea, known as Continuous Positive Airway Pressure (CPAP) machines. Users of those machines were advised to halt usage. Around two-thirds of Philips, CPAP machine sales are in the United States, a Reuters report states.

The other 20% of affected devices were ventilators. Doctors and patients using life-sustaining ventilators should first consider whether the potential danger from the foam outweighs other risks, the company said.

Company statement

The company has put out a voluntary recall notification on its website. "For any query, one needs to register the device(s) on the recall website or follow these process: The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues," the notification said.

It added, "The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Call 1-877-907-7508 if you cannot visit the website or do not have internet access.

For patients using life-sustaining mechanical ventilator devices:

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. 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.

If your physician determines that you must continue using this device, use an inline bacterial filter. Consult your Instructions for Use for guidance on installation.

For patients using BiLevel PAP and CPAP devices:

Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment."

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