Philips (NYSE: PHG) + continues to have serious respiratory device recalls, more than three years into a major safety crisis for its Respironics business. 

Yesterday, the FDA designated a recall of Trilogy Evo, Trilogy EV300, Trilogy Evo O2, Trilogy Evo Universal ventilators as Class I, it’s most serious level. Philips says the action involves roughly 90,000 units worldwide, including about 67,000 in the U.S.

The affected devices have had numerous software errors, including an inaccurate display of oxygen being delivered to the patient, false power loss or battery depleted alarms, volume measurement inaccuracies, and more. There is also a previously reported safety issue involving accumulation of environmental debris on the internal machine flow sensor, which could partially block pressure, volume, or air flow.

The have been nine injuries and one death related to the problems, according to the FDA.

The FDA said Philips Respironics sent all affected customers an Urgent Medical Device Correction – Update on July 16 that they immediately update device software to the latest version, and follow a user manual addendum that requires ta Phillps-approved particulate filter to prevent environmental contamination.

The FDA has more details about the Class I recall on its website.

In a statement shared with MassDevice, Philips said that its Respironics business has intensified its efforts to strengthen patient safety and product quality across the company. “This has resulted in more frequent news flow on identified issues, including the correction activities for field safety notices previously sent to customers in 2023 and 2024, which the FDA has now communicated about.”

The company also noted that the July update communicated a major software update to address several previously communicated safety issues. “There are no new health hazards communicated in this notification. The notice indicates how prior field safety notices are being corrected. The notice also includes information on labeling and instruction manual updates. Philips Respironics is also addressing new non-safety issues in these updates.”

Since early 2021, Philips has been grappling with recalls involving millions of CPAPs and other respiratory devices. (Here’s MassDevice‘s timeline of Philips’ problems.)

When it comes to the major recall involving sound abatement foam that could potentially degrade and get into airways, Philips in April finalized a consent decree with the U.S. Department of Justice and FDA that provided a roadmap for resolving the recall. Philips soon settled personal injury claims in the U.S. for $1.1 billion and is also paying at least $613 million to settle economic loss claims.