Topline
Shares of Dutch electronics and health giant Philips saw dropped early Wednesday after the Food and Drug Administration published a warning about a safety issue with the company’s sleep apnea machine Tuesday night.
Facade with logo and sign at the regional headquarters of technology company Philips.
Key Facts
Philips’ Amsterdam-listed shares fell to $20.4 (€18.6) in afternoon trading, down nearly 5% on the previous day.
The company’s New York-listed shares were down more than 3.7% to $20.4 in pre-market trading.
The FDA’s warning covers Philips DreamStation 2 Continuous Positive Airway Pressure machine, used by patients suffering from sleep apnea.
The health regulator urged patients and health care professionals to closely monitor the machine for “signs of overheating.”
The agency said the warning is in response to 270 medical device reports “associated with thermal issues such as fire, smoke, burns, and other signs of overheating,” while using the DreamStation 2.
Crucial Quote
In a statement, the company said it is “in discussions” with the FDA about the reports. The company said it had reviewed and analyzed the reports in question, adding: “The devices can continue to be used provided that the safety instructions in the instructions for use for the DreamStation 2 sleep therapy device are followed.”
Key Background
This is the latest safety issue to impact Philips’ CPAP machines, which had previously been recalled due to concerns about a foam component in its build. The 2021 recall included the predecessor to the DreamStation 2 after it was discovered that a foam component on these machines had the potential to degrade into small particles that could be inhaled by the user. The company warned at the time the particles may be toxic and cancer-causing.
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