The US Food and Drug Administration (FDA) issued an update to its safety communication regarding Philips’ recall, saying the manufacturer has overstated the number of replacement and remediated devices it has shipped. 

“To provide transparency for consumers who are awaiting a replacement device, the FDA is clarifying that the number of replacement and remediated devices that have been shipped to consumers in the US is considerably less than the 2,460,000 number of ‘new replacement devices and repair kits’ posted on Philips’ website,” reads the update. 

The FDA says the 2,460,000 number includes manufactured repair kits that Philips shipped internally to its repair facilities, “which are not replacement or remediated devices that have been shipped to consumers.” 

“We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device,” says the FDA in the update. 

“We are looking into how to best address the concern of the FDA,” Philips states in an email to Sleep Review. “To date, we have been reporting on the total amount of new replacement devices and repair kits that have been produced and shipped to the country of destination. This means that not all of these devices are already in the hands of patients. To date, approximately 2.2 million devices have been remediated in the US.”

The FDA encourages consumers to contact Philips for an update on the status of their replacement device.

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