That warning follows an estimate by the US Food and Drug Administration (FDA). The regulator has classified the recall from Philips in the highest risk category, the so-called Class 1.
There are already dozens of incidents and multiple injuries reported in the United States from devices that were recently recalled, the FDA said, but no deaths.
Philips has already set aside hundreds of millions of euros in connection with the matter. But CEO Frans van Houten thought it was too early to say anything about possible damage claims as a result of the defects when the quarterly results were presented last week. It may take a long time before such a case comes to court, Van Houten indicated.
In total, the company has sold 3 million to 4 million devices worldwide that need repair or replacement, of which an estimated tens of thousands in the Netherlands.
This mainly concerns the devices with masks that people wear at night to prevent sleep apnea. The health risks are caused by sound-damping foam rubber that is incorporated in the devices. These can release particles that can be swallowed or inhaled by the user.
Later research showed that the foam can also release certain chemicals. Especially if the device is not cleaned properly. This foam can release harmful gases in response to certain substances.
Investors were shocked by the news of the FDA’s assessment. At the end of the morning on Wednesday, Philips was by far the largest decliner among the main funds on the Amsterdam stock exchange.
The healthcare technology company is losing 3% of the market value.
FDA watchdog: Philips ventilator recalled dangerous | Financial
Source link FDA watchdog: Philips ventilator recalled dangerous | Financial