Philips widens scope of recall

AMSTERDAM, the Netherlands – Philips now expects to remediate about 5.2 million recalled devices, forcing the company to increase its provision for the program by another EUR 225 million and to slightly delay its conclusion. 

The company felt it had to be “more lenient” on accepting recall registrations coming in for older devices, says CEO Frans van Houten. 

“It’s difficult to deny a patient with an older unit a repair if they are still using it and sometimes patients have two units that they use alternatingly and we felt it was difficult to say no on an arbitrary five-year limit, even though we know that in the U.S. patients are entitled to new reimbursement,” he said. “But the fact that there is new reimbursement does not mean that they should stop using the old product, right?” 

To date, Philips says it has produced 1.5 million repair kits and replacement devices, with about 700,000 in the hands of customers. 

Philips expects to complete remediation in the fourth quarter of 2022. Previously, the company believed it could conclude the program 12 months after approval by the U.S. Food and Drug Administration, which it announced on Sept. 1. 

“While the first approval came in August, September of last year, there were also many that came in later, right?” van Houten said. “So, the 12 months horizon to execute the recall is still about intact. We are not going to be materially different in our statements.” 

In another update, Philips says particulate testing and analysis on its devices are expected to be completed in the second quarter of 2022. The company announced in December that VOC testing and analysis indicated VOCs do not exceed safe exposure thresholds specified in the applicable safety standards.  

“Originally, we were on a faster track on particulates testing,” van Houten said. “In dialogue with the regulator, the scope of testing on the particulates has been extended – let’s say, a broader test with more ISO standards, as if the particulate is an implanted device. That is a longer test protocol.” 

Testing is also under way on the silicone-based foam that Philips is now using in replacement devices, per the FDA’s request. 

“I want to emphasize the silicone is safe and you can also derive (that) from the fact that the FDA said the recall and replacement can continue,” van Houten said. “I think it relates to a desire to have a strong rigor around this, but I want to emphasize that all of our own tests show that silicone is safe.”