- Shares in Dutch health technology company Philips fell to the lowest level on the European benchmark on Friday.
- The US Food and Drug Administration (FDA) said overnight that it did not believe that “the tests and analyzes that Philips has published to date are sufficient to fully assess the risks posed to users by the recalled devices. “
- In response to the FDA, Philips said in a statement that “patient health and well-being is our top priority.”
Philips office building in Warsaw, Poland on July 29, 2021. (Photo by Beata Zawrzel/NurPhoto via Getty Images)
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Shares in Dutch health technology company Philips fell to the lowest point on the European benchmark on Friday after the U.S. drug regulator deemed its handling of a major product recall inadequate.
The Amsterdam-listed stock was trading more than 7% lower at midday London time, paring some losses after falling as much as 10% earlier in the session.
The announcement is another setback for Philips over the recall of millions of ventilators used to treat sleep apnea, which CEO Roy Jakobs said earlier this year was a “top priority” for the company.
The US Food and Drug Administration (FDA) said overnight that it did not believe that “the tests and analyzes that Philips has published to date are sufficient to fully assess the risks posed to users by the recalled devices. “
The FDA said it believed additional testing was necessary and pointed out that Philips was eager to comply with this request.
In response to the FDA, Philips said in a statement that “patients’ health and well-being are our top priority, both in terms of providing replacement devices and testing to provide greater clarity on the safety of the sleep and ventilator devices.” “. the callback.”
The company added that it shares the same goal as the FDA and other regulators of “ensuring the highest standards of patient safety and quality in the delivery of health care.”