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FDA Repeatedly Rejected Safety Claims Made by Philips After the CPAP Recall but Waited to Alert the Public, Emails Show

Philips claimed its recalled CPAP devices were safe based on new tests, but the FDA quickly disputed these claims, emails show.

United statesBrian fitzpatrickMichaeld sallahDebbie cenziperHisham elzayatRichard callenderMichael korshDenise hamptonPhilips respironicsKushal kadakiaPhilips respironicBob loweDepartment of justiceDrug administrationHarvard medical schoolOffice of health technology

FDA Repeatedly Rejected Safety Claims About Philips Breathing Machines, Emails Show — ProPublica

As Philips reassured patients that millions of recalled machines were safe, internal emails show federal regulators privately told the company its testing didn’t account for the impact of long-term harm from tainted devices.

United statesBrian fitzpatrickLiz moughon propublicaBob lowePhilips respironicKushal kadakiaMike wereschaginDenise hamptonPhilips respironicsHisham elzayatRichard callenderRobert loweDepartment of justiceOffice of health technologyDrug administrationHarvard medical school

FDA repeatedly rejected safety claims made after recall of a CPAP but waited to alert the public, emails show

Philips Respironics received thousands of complaints about a dangerous defect in its breathing machines but kept them secret for years as stock prices s.

United statesBrian fitzpatrickPhilips respironicsBob loweHisham elzayatRichard callenderDenise hamptonKushal kadakiaPhilips respironicDrug administrationOffice of health technologyHarvard medical schoolDepartment of justicePittsburgh post gazetteHealth technology

FDA repeatedly rejected safety claims made by Philips after the CPAP recall but waited to alert the public, emails show

As Philips reassured patients that millions of recalled machines were safe, internal emails show federal regulators privately told the company its testing didn’t account for the impact of long-term harm from tainted devices.

United statesRichard callenderPhilips respironicBrian fitzpatrickHisham elzayatPhilips respironicsDenise hamptonBob loweKushal kadakiaOffice of health technologyDrug administrationDepartment of justiceHarvard medical schoolPulitzer prize winningBig storyWith every breath

Staff Fellow (Biomedical Engineer/ Optical Scientist) - FDA/ Center for Devices and Radiological Health (CDRH), Silver Spring, MD, United States

Job: Staff Fellow (Biomedical Engineer/ Optical Scientist) - FDA/ Center for Devices and Radiological Health (CDRH) Silver Spring, MD, United States

United statesDivision of reproductiveDrug administrationUs department of educationElectronics engineeringRadiological healthIntegrity officeStaff fellowship programSelective service systemOffice of health technologyOffice of product evaluationHuman factors programStaff fellowOptical scientistSilver springProduct evaluation

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