French prosecutors have opened a preliminary investigation into Philips over the major recall of sleep apnea devices. This happened after several complaints about technical problems with the devices of the Dutch medical technology group.
In certain Philips apnea devices, insulating foam can crumble, potentially causing serious health damage to patients. As a result, the company has to recall about 5.5 million devices. The problems became known last year, but documents from the US regulator FDA show that there were indications that something was wrong as early as 2015.
Multiple complaints
A spokesperson for the Paris prosecutor says that he has received several complaints about the Philips devices since June. These included deception, endangering the life of others and the administration of harmful substances. In France, Philips recalled 370,000 devices due to the defect, about a third of which have been replaced, according to news channel France Info.
Philips also has to deal with justice in the United States. The listed company hopes to reach a settlement here, Philips reported in its second-quarter figures.
48,000 reports
From May through July, the FDA received 48,000 reports of incidents involving the apnea devices in the US, much more than in the previous 12 months. This included 44 cases of people who may have died as a result of damage from using the Philips equipment.
In the previous period, the FDA had associated 124 more cases with complaints about sleep apnea devices. It has not been established whether the reported deaths and other health complaints were actually caused by the devices.
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