Phillips: Small risks in breathing apparatus after further testing

The Institute of Medical Technology says that the risks of health problems for people who use Philips sleep apnea devices are very small. The company says it will confirm initial results from the summer as tests of the first generation of devices, now called DreamStation devices, are complete. About two-thirds of recalled devices fall into this category.

In total, Philips will have to replace 5.5 million devices. The company now manufactures 90 percent of those replacement devices. These are on their way to patients or healthcare providers, who will deliver them to patients. Philips achieves its self-imposed target for this year.

Problems with sleep apnea machines are related to the foam insulation in the machines. It may crumble or release chemicals after contact with certain cleaning products. In both cases, Phillips says the risks are within safe limits.

According to Phillips, the risk of damage to the insulation foam is also very small. The company previously said 0.5 percent in the U.S. unless devices are cleaned with ozone. In Europe, the chance is 0.04 percent or one in 2500 devices affected by the problem. No infected foam was found in the Japanese devices.