Philips Clarifies Recall Numbers Amid FDA Rebuke

WASHINGTON, D.C.—More than a year-and-a-half after Philips announced the voluntary recall of 3 million to 4 million of its sleep apnea devices and ventilators, the U.S. Food and Drug Administration (FDA) released a statement claiming the number of replaced devices reported on the company’s website is “considerably less” than what has actually been shipped to consumers in the U.S. 

The FDA statement, released on April 13, alleges the 2.46 million “new replacement devices and repair kits” posted on the Philips website includes manufactured repair kits shipped internally to Philips repair facilities, “which are not replacement or remediated devices that have been shipped to consumers,” the FDA said. 

Following this claim, Philips clarified with a statement to Reuters that “2.2 million devices it has repaired or replaced in a major recall of respiratory devices are actually in the hands of patients in the United States.”

This conflict follows another recall from Philips, as it continues to struggle with the ongoing recall of its devices. On April 7, Philips issued a Class I recall for certain reworked DreamStation CPAP and BiPAP machines, saying some of the devices had been assigned incorrect or duplicate serial numbers during the initial programming. This error can lead to therapy being delivered using the wrong prescription or factory default settings, or failing to deliver any therapy at all, with no identification that it is not working the way the doctor prescribed. 

“Incorrect therapy or therapy failure may lead several health conditions such as respiratory failure, heart failure, serious injury, and death,” a statement from the FDA said. “Philips has received 43 complaints about this issue. There are currently no reported injuries or deaths.”

According to the FDA, a Class I recall is the most serious type of recall and use of the devices may lead to serious injuries or death.