FDA warns about Philips respiratory recall

The Food and Drug Administration (FDA) sent a warning notice to Philips Respironics after patients and healthcare providers claimed they were unaware that a particular breathing aid was recalled.

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In June 2021, certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and biphasic positive airway pressure (BiPAP) machines were inhaled by users with collapsed foam components and were toxic and carcinogenic. Impact of.

“This particular form can break and cause serious injuries, can be life-threatening, cause permanent disability, and / or require medical intervention to prevent permanent injury to the user. I need it, “the FDA said in a Thursday notice.

Specific Phillips Respironics Ventilator, Continuous Positive Airway Pressure (CPAP) and Non-Phaseful Positive Airway Pressure (BIPAP) Machines

Federal agencies have recalled to all device users, durable medical equipment suppliers, distributors, retailers, and healthcare providers of the serious harm to public health caused by the deterioration of polyester-based polyurethanes. We are instructing the company to notify us of “unreasonable risks”. (PE-PUR) The sound abatement form used in these products “according to the FDA’s notice.

DreamStation ASV, also known as “DreamStationBiPAPautoSV”. (Philips Respironics)

As part of this order, Philips must inform the patient about the risks associated with using ozone cleaners on the recalled device at the time of the recall. The company also needs to instruct device users on how to register their device on the Philips website (agency). Continued.

The FDA said Philips should even try to provide monthly updates to device users who register their devices, including information about the replacement process.

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Authorities said “the company’s notification efforts to date have been inadequate,” and said this measure was necessary.

“The FDA is unaware of the recall and has heard complaints from patients and durable medical device suppliers who are unaware of the recall and lack information on the next steps in the recall process,” said the director of the FDA’s Device Center. Dr. Jeff Schlen said. Radiation health.

The FDA says it has been working with the company on the effectiveness of public communication since the first recall. The FDA has expressed concern that a significant proportion of patients and consumers using recalled products may not be aware of them. The health risks posed by those products. “

However, Philips told FOX Business that the company “is doing everything possible to support its customers, clinicians, and their patients, and will continue to do so,” and has worked with the FDA since the recall began. He said he was doing it.

Philips recall

The FDA said Philips’ notification efforts to date were “insufficient.”

Philips added, “We are aiming to further accelerate the exchange process. There are no upcoming orders we have not yet made.”

On Thursday, the company announced an update on its website: “After two comprehensive customer and patient engagements, Philips Respironics has reached most of the US installation base and approximately 2.6 million devices have been registered.”

The company also said it would work with durable medical device suppliers to “directly contact patients and other end users who may not have received recall notifications yet.”

This is a list of recalled devices manufactured between 2009 and April 26, 2021.

  • A series BiPAPA30
  • A series BiPAPA40 (ventilator)
  • A Series BiPAP Hybrid A30
  • A series BiPAPV30Auto (ventilator)
  • C series ASV (ventilator)
  • C series S / T and AVAPS
  • DreamStation
  • DreamStation ASV
  • DreamStation Go
  • DreamStation ST, AVAPS
  • Dolma 400
  • Dolma 500
  • E30
  • Garbin Plus, Aeris, LifeVent (ventilator)
  • OmniLab Advanced +
  • REMstar SE Auto
  • SystemOne ASV4
  • SystemOne (Q series)
  • Trilogy 100 (ventilator)
  • Trilogy 200 (ventilator)

Company also recalled Specific Trilogy Evo ventilator It was distributed from April 15, 2021 to May 24, 2021.

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