MURRYSVILLE, Pennsylvania—Philips Respironics has remediated 2.683 million patients affected by its sleep device recall as of the beginning of February—99% of those it could—the company announced.
As of Feb. 2, the company said, it had remediated all but 80,000 of the “actionable” registrations, which it defined as those that included all information necessary to complete the process. Remediated patients include:
- Those who have received a new, recertified or alternative device to replace an affected unit
- Those who have devices shipped to their durable medical equipment (DME) providers directly handling patient remediations
- Those who have received final payment
The company announced in January that it closed its online portal for U.S. sleep patients—although people who have recalled devices are still able to return them.
Ventilation Recall Update
For ventilation devices, the company also said it had received 133,000 actionable registrations as of Feb. 2, defining “actionable” as those that contain the information needed to complete the remediation and the devices are in possession of the customer. It also said it had remediated 79,000 devices in the United States as of Feb. 2.
“We are committed to remediating affected ventilators in alignment with the relevant competent authorities, and continue to work with independent testing laboratories to conduct extensive testing and analysis of the affected devices,” the company said on its website.
Sales Boost Reported
In its recent earnings report released Feb. 10, Philips said it made a 1.025-million Euro payment for U.S.-based medical monitoring and personal injury settlements related to the Respironics recalls.
“We also continue to address the consequences of the Respironics recall and relentlessly work towards resolution of the FDA warning letter issued last October,” Philips President, CEO and Chairman Roy Jakobs said. “We integrally designed new innovations and act fast and comprehensively when improvement opportunities arise."
At the same time, Jakobs said, it more than doubled its 510(k) clearances from the FDA over the past two years.
“Together, this reflects simpler, more standardized quality system that embeds patient impact and quality at design stage, enabling high-quality innovation to support patients at scale,” he said.
The company said comparable sales for its connected care division, which includes sleep and ventilation,saw sales increase 3% for the year and adjusted earnings before interest, taxes and appreciation (EBITDA) increased to 10.7%