“Philips has presented a false choice of foregoing essential, sometimes life-saving care or using a defective product that could itself result in death.”
[WASHINGTON, D.C.] – Amid alarming reports, U.S. Senator Richard Blumenthal (D-CT) raised serious concerns about the recent recall of more than a dozen models of Philips Respironics ventilators, CPAPs, and BiPAPs, and the inability of millions of Americans to get swift access to safe, alternative breathing machines. Philips Respironics, a subsidiary of Philips North America, recalled the devices in June, and last month, the U.S. Food and Drug Administration (FDA) classified this as a Class I recall—the most serious type of recall—due to grave health risks stemming from a sound abatement foam in the machines.
“I have heard from a number of my constituents that this massive recall has left them and many others around the country struggling to find a safe, effective alternative,” wrote Blumenthal to Philips North America Chief Executive Officer Vitor Rocha. “[E]ven after several months, too many patients have yet to receive the promised repair kits and replacements, leaving users ‘stranded,’ and many patients may not even know of the recalled status of their device.”
Blumenthal pressed Philips to provide the number of patients impacted by this recall, those who have been provided with safe replacement devices, and the company’s timeline for submitting a permanent solution plan to the FDA to protect patients in the future.
“The current situation is untenable, unacceptable, and must be immediately rectified,” Blumenthal continued. “I urge Philips to continue its outreach to impacted patients, immediately expedite its replacement and repair program, submit a mitigation plan with sufficient evidence to FDA for authorization, and work to ensure that such a mass recall does not occur again in the future.”
The full text of the letter can be found here.