43 complaints were received on certain Philips models, leading to Class I recall.
The Food and Drug Administration (FDA) issued a Class I recall, the most serious type, for certain CPAP machines made by Philips Respironics. CPAP (continuous positive airway pressure) machines are used by people with sleep apnea to keep up an even breathing pattern during sleep. Sleep apnea causes airways to collapse, sometimes hundreds of times during a single night, leading to a number of diseases linked to oxygen deprivation or even death.
Some of Philips’ DreamStation1 CPAP machines have been manufactured and programmed with incorrect or duplicate serial numbers. “This duplication can cause therapy to be delivered using the wrong prescription or factory default settings,” the FDA said in the recall notice. “Additionally, it may fail to deliver any therapy at all. There is no warning or indication to the user that the DreamStation is not working the way the doctor intended or prescribed.”
The FDA received 43 complaints that led to the decision to issue the recall. There have been no reports of injury or death due to these machines malfunctioning.
As the Lord Leads, Pray with Us…
- For Commissioner Califf as he oversees the Food and Drug Administration.
- For FDA officials as they field and review consumer responses and complaints.
Sources: CNN, CBS News
