Philips is recalling 1,233 sleep apnea devices in France and the United States. This was stated by the spokesperson of the Health Technology Committee. These are DreamStation-type devices that, among other things, help people with sleep apnea during sleep.
US medical regulator FDA has issued an urgent warning, saying that using the devices could cause serious injury or death. DreamStations have already been fixed after fatal defects, which is why 5.5 million devices were previously recalled worldwide.
In the U.S., 1,088 devices are being recalled, the spokeswoman said, while others are from France. Half of these have already been transferred or are on their way to customers and patients, he notes.
Incorrect or duplicate serial numbers
The devices are from a specific batch and are being recalled because incorrect or duplicate serial numbers were assigned during programming. A device with duplicate serial numbers in circulation could lead to patients receiving the wrong treatment from the DreamStation machine. According to the FDA, it is also possible that there is no cure. If this is the case, DreamStation will not issue a warning.
According to the American Medical Watch, failed treatment with DreamStation can lead to “respiratory problems, heart failure, serious injury, and death.” According to the FDA, Philips received 43 complaints about problems with the devices, but no injuries or deaths. On February 10, the FDA said that Philips informed customers and patients about the problems.
5.5 million devices
Philips previously had to recall 5.5 million devices worldwide from the first-generation DreamStations. Basic issues related to foam insulating in machines. It may crumble or release chemicals after contact with certain cleaning products. In both cases, Phillips said the risks were within safe limits.
A total of 346 deaths were reported that may have been related to faulty devices. CEO Roy Jacobs expects to be able to close a deal this year with patients who suffered economic damages as a result of the choking issue by the end of March.
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