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Apr 15, 2024

Philips Respironics has a Class I level ventilators recall

August 15, 2023 By Chris Newmarker The FDA has posted information on its website about another serious recall involving Philips Respironics products. The news comes the same week that Philips got a

August 15, 2023 By Chris Newmarker

The FDA has posted information on its website about another serious recall involving Philips Respironics products.

The news comes the same week that Philips got a vote of confidence from Exor, the investment arm of Italy’s wealthy Agnelli family, which bought a 15% stake in the Dutch medtech giant to become its largest shareholder. Media reports estimate the deal is worth $2.8 billion. Exor gains the right to nominate a member of Philips’ Supervisory Board.

The latest Class I recall covers 73,000 Philips Respironics Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators in the U.S. It’s the Philips subsidiary’s 11th serious recall listed on the FDA’s Medical Device Recalls webpage since 2021 — when a global recall involving millions of CPAPs and other respiratory products with potentially degraded sound abatement foam sidelined Philips from the market.

According to the FDA, Philips initiated the recall of Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators on March 22 after detecting dust and dirt from the environment in the air path of some devices. Extended exposure to environmental contaminants such as dust and dirt can lead to buildup that may block air vents and cause the device to stop delivering the right amount of air pressure or air volume/flow.

Philips has received 542 reports about the problem, the FDA said. There are currently two reported injuries and one death.

In a statement shared with MassDevice by a Philips spokesperson, the company said it notified the FDA of the potential issue in April and that it immediately informed relevant hospitals and began remediation in May. The FDA posted information about the Class I recall yesterday, but the Class I designation came on June 2. The TGA in Australia has deemed it Class 1, and Health Canada says the recall is Class 2.

The reported death cannot presently be attributed to the potential ventilator problems, according to Philips. “The device related to the patient death report was returned to Philips for investigation, without filters installed, and with severe contamination present. The device operated as intended where numerous high-priority alarms were confirmed.”

Philips also said: “Affected devices may continue to be used in accordance with their instructions for use and the guidance provided by the issued field safety notice. This includes using a particulate filter to prevent accumulation of environmental debris that can cause a device malfunction. Using this filter was previously optional and is now required.”

Filed Under: Featured, Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance, Respiratory Tagged With: Philips, Philips Respironics