Just a few months after kicking off a June 2021 recall that would ultimately grow to encompass 5.5 million respiratory devices, Philips began a repair-and-replace program to fix the affected CPAP and BiPAP machines, ventilators and other devices. Though the company originally said the remediation efforts would only take about a year, it updated that timeline last summer to push the finish line into 2023.
Now, about a year and a half into the repair-and-replace program, Philips’ website states that 90% of the production of all needed replacement devices and repair kits has been completed and that 2.46 million of the devices and kits have been “shipped in the U.S.”—but the FDA is taking issue with the latter figure.
According to an update the agency added Thursday to its webpage regarding the recall, “the number of replacement and remediated devices that have been shipped to consumers in the U.S. is considerably less than the 2,460,000 number of ‘new replacement devices and repair kits’ posted on Philips’ website.”
The regulator noted that the tally includes not only the number of devices that have been completely repaired or replaced and sent back to users, but also the number of repair kits that Philips has sent to facilities, which would then still need to do the actual repairs on recalled machines.
That could potentially cause some confusion for users of affected devices: “We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device,” the FDA noted in the update, before encouraging users to contact Philips directly for updates on the status of their reworked devices.
In a statement sent to Fierce Medtech, Philips clarified that so far, about 2.2 million repaired or replacement devices have been shipped to U.S. consumers.
“We are looking into how to best address the concern of the FDA,” Philips said in the statement. “To date, we have consistently reported on the total amount of new replacement devices and repair kits that have been produced globally, as well as the total amount of new replacement devices and repair kits shipped to a given country of destination. This means that not all of these devices are already in the hands of patients.”
This isn’t the first time the FDA has taken issue with Philips’ actions regarding the June 2021 recall.
In March 2022, the agency issued a notification order that gave the Dutch devicemaker 45 days to notify all device users, durable medical equipment suppliers, distributors, retailers and healthcare providers about the recall and its associated health risks. At the time, the FDA said it had “determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate.”
A few weeks later, in early May, the regulator proposed another order that would require Philips to repair, replace or refund all affected machines—therefore adding another layer of urgency and oversight to the repair-and-replace program, which had already begun by that point—though the FDA still has yet to officially implement the order.