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The Food and Drug Administration (FDA) sent a warning notice to Philips Respironics after patients and medical suppliers claimed they were unaware that certain breathing assistance machines had been recalled.
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In June 2021, certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines had been recalled over concerns that a foam component could disintegrate and be inhaled by the user, possibly causing health issues including toxic and carcinogenic effects.
"This particular foam may break down and can result in serious injury, which can be life-threatening, cause permanent impairment and/or require medical intervention to prevent permanent injury to users," the FDA said in its Thursday notice.
The federal agency is ordering the company to inform all device users, durable medical equipment suppliers, distributors, retailers and health care providers about the recall and the "unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products," according to the FDA notice.
DreamStation ASV, also known as DreamStation BiPAP autoSV. (Philips Respironics )
As part of this order, Philips is also required to inform patients regarding the risks associated with using ozone cleaners on the recalled devices on the recall. The company should also give instructions to device users on how to register devices on the Philips website, the agency continued.
The FDA said Philips should even try and provide monthly updates to device users who register their devices, including information on the replacement process.
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The agency said this action is necessary, saying the "company’s notification efforts to date have been inadequate."
"The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process," said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
Since the initial recall, the FDA says it's been working with the company about the effectiveness of its communications with the public. The FDA said it "has expressed concern that it is likely a significant portion of patients and consumers using the recalled products are unaware of the health risks presented by those products."
However, Philips told FOX Business that the company is "doing and will continue to do everything possible to support our customers, clinicians and their patients" and that it's been cooperating with the FDA since the start of the recall.
The FDA said Philips' notification efforts to date "have been inadequate."
"We aim to further accelerate the replacement actions," Philips said, adding that "there isn’t anything in the Order that we have not already been doing and are about to do."
On Thursday, the company issued an update on its website saying in part: "following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country."
The company also noted that it will be working with its durable medical equipment suppliers "to allow the company to directly contact those patients and other end-users that may not yet have received notice of the recall."
Here is a list of the recalled devices made between 2009 and April 26, 2021:
- A-Series BiPAP A30
- A-Series BiPAP A40 (ventilator)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto (ventilator)
- C-Series ASV (ventilator)
- C-Series S/T and AVAPS
- DreamStation
- DreamStation ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- E30
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
The company also recalled certain Trilogy Evo ventilators that were distributed from April 15, 2021 to May 24, 2021.
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March 12, 2022 at 02:15AM
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FDA issues warning over Philips breathing machine recall - Fox Business
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