Philips says limited risks on recalled products

AMSTERDAM: Dutch health technology company Philips said yesterday tests on its respiratory devices involved in a global recall had shown limited health risks.

The company rocked investors last year by recalling millions of breathing devices and ventilators used to treat sleep apnea, because foam used to dampen noise from the devices might degrade and become toxic, carrying potential cancer risks.

Fears of large litigation bills have since wiped 70% off the company’s market value. Philips shares were up 3.5% yesterday morning.

“We can state that the whole product complies with safety norms. That is very encouraging news,” Chief Executive Roy Jakobs told Reuters.

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

The company said results also showed that exposure to volatile organic compound emissions was not expected to result in long-term health consequences for patients.

Philips had already said earlier this year that tests indicated foam degradation was very rare and was linked to the use of unauthorised ozone-based cleaning products.

It said further tests now showed machines cleaned with those products were 14 times more likely to have significant visible foam degradation than those treated with authorised products.

Last year, SoClean Inc, an independent supplier of ozone-based sanitising systems, filed a lawsuit against Philips, which it blamed for plummeting sales due to allegations that ozone-based products had caused the problems with the sleep apnea devices.

The US Food and Drug Administration is considering the results and “may reach different conclusions”, Philips said.

The company said it expected to finish the recall and replacement of all affected products in the first half of 2023, as it has now produced 90% of all needed replacement devices.

The test and research programme has been conducted with five independent, certified testing laboratories and the results have been reviewed by qualified experts and Philips Respironics, as well as an external medical panel, the company said.