Philips announced a 2021 recall of these DreamStation sleep apnea devices. Users risked inhaling or swallowing pieces of toxic anti-cushion foam.
According to Philips, PSN Labs overestimated the danger the devices posed to patients due to incorrect testing and analysis, before seeking to “cover up” its errors.
Based on these results, Philips decided to recall 5.6 million devices worldwide, a matter that cost a total of between 4 and 5 billion euros, according to the Dutch news agency ANP, and resulted in the elimination of thousands jobs.
“Unacceptable Behavior”
“This legal action seeks to hold PSN accountable for its unacceptable behaviour,” said a spokesman for the Dutch group. “Philips Respironics would have conducted a different and more targeted recall if PSN had not made serious errors and grossly overestimated the risk to patients, thereby causing undue concern,” he added.
Philips has since said it has conducted “significant independent testing” of the foam in its devices. In 2023, five independent, accredited laboratories found no notable harm to patient health, according to Philips.
“Through this legal action, we are holding PSN accountable for the errors it made, and in particular for the reprehensible behavior of covering up its errors after we became aware of them,” the spokesperson stressed.