The number of replaced apnea devices would therefore be a lot lower than reported, the FDA fears. This may affect the time patients have to wait to receive a new or repaired apnea device.

Philips itself says on its website that it has already delivered 2.46 million devices and repair kits in the United States. The company declares its willingness to address the concerns of the FDA and to see how this can best be done. But since the recall began, the company has followed the same reporting method, it sounds. According to Philips, 2.2 million apnea devices have actually been replaced in the US.

Incidentally, not only the US health authorities are impatient about the duration of the recall. In Italy, a judge ruled that Philips must complete the recall before the end of this month, which Philips says is an “impossible task”. The company is considering an appeal in that case.

The worldwide recall is related to potential health problems that can be caused by crumbling insulation foam. The foam may also give off harmful gases when it comes into contact with certain cleaning agents. The case has already cost the company about a billion euros.