With Every Breath
Millions of Breathing Machines. One Dangerous Defect
Philips Respironics received thousands of complaints about a dangerous defect in its breathing machines but kept them secret for years as stock prices soared. The devices, including the popular DreamStation for sleep apnea, went to children, the elderly and veterans before the global giant announced a massive recall.
Amid Recall Crisis, Philips Agrees to Stop Selling Sleep Apnea Machines in the United States
The breathing machine manufacturer has faced relentless criticism over its handling of the 2021 recall of millions of devices. Philips must meet the requirements outlined in an agreement with the Justice Department before it can resume sales.
Congressional Watchdog Will Launch Inquiry Into FDA Oversight of Medical Device Recalls
Sens. Dick Durbin and Richard Blumenthal asked the Government Accountability Office to investigate the regulatory agency, citing ProPublica and Pittsburgh Post-Gazette reports on the 2021 recall of Philips breathing machines.
“Unacceptable”: Senators Call on GAO to Probe FDA’s Oversight of Medical Devices, Citing Series on Philips CPAP Recall
Sens. Dick Durbin and Richard Blumenthal sent a letter noting how the agency missed opportunities to protect the public from faulty medical devices, citing reporting by ProPublica and the Pittsburgh Post-Gazette.
U.S. Senator Expands Call for Crackdown on Philips Respironics
Sen. Richard Blumenthal’s letter to two federal agencies comes after a ProPublica and Pittsburgh Post-Gazette investigation found Philips kept secret thousands of warnings about its tainted breathing machines.
Senator Calls for DOJ Action Against Philips for Keeping CPAP Machine Complaints Secret
The FDA also said it is “unsatisfied” with the company’s response to the crisis. Share prices dropped in early trading.
