Tag Archive for: Philips

The company announced that it will not sell new devices to treat sleep apnea in the United States in the coming years as it works to comply with a settlement with the Food and Drug Administration.

The Dutch medical devices maker started the recall process on Nov. 30 this year and has recalled 150 devices in the United States.

Philips shares fell more than 6% on Wednesday after the U.S. Food and Drug Administration said it is alerting patients of a new safety issue with machines made by the group that are used for the treatment of obstructive sleep apnea.

The U.S. Food and Drug Administration (FDA) said it is still not satisfied with how Dutch healthcare technology company Philips has handled a major product recall and the company should conduct additional risk testing.

Dutch medical devices maker Philips said on Tuesday that independent tests have shown that the use of its respiratory devices involved in a major global recall did not cause health risks for patients.

Today the company clarified that 2.2 million devices it has repaired or replaced in a major recall of respiratory devices are actually in the hands of patients in the United States.

Fears of large litigation bills have since wiped 70% off Philips’ market value.

The FDA said the silicon foam used in some reworked ventilator models may separate from plastic backing due to adhesive failure and can reduce the air flow as well as cause debris contamination. The issue can lead to patient injury or death.

Dutch health technology company Philips will scrap another 6,000 jobs worldwide as it tries to restore its profitability and improve the safety of its products following a recall of respiratory devices that knocked off 70% of its market value.

Philips said the latest tests indicated that exposure to particulate matter emissions from degraded foam in DreamStation devices was “unlikely to result in an appreciable harm to health in patients”, provided the machines had not been treated with ozone-based cleansing products.