Exclusive Breaking News : Inside Information on the FDA Safety Notification for Philips DreamStation 2Patient safety and quality are Philips Respironics’ top priorities. Philips Respironics is in talks with the United States Food and Drug Administration (FDA). About reports it filed with the FDA about probable thermal concerns. In the humidifier of the DreamStation 2 sleep therapy equipment while in operation.
Philips Respironics filed these approximately 270 reports over the last three months. Covering a three-year period as a result of a retrospective evaluation of potential heat. Concerns related to DreamStation 2 since the product’s inception.
The FDA has issued the following safety communication: Keep an eye out for signs of overheating in Philips DreamStation 2 CPAP machines: FDA Safety Communication via FDA.
In compliance with its regulatory standards, Philips Respironics reviewed and analysed reports of potential heat concerns. The devices can be used again as long as the safety guidelines in the DreamStation 2 sleep therapy device instructions are followed.
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