"The FDA has identified this as a Class I recall, the most serious type of recall," the agencysaidFriday in issuing a new alert about the the devices. The repaired CPAP machines were given the wrong or a duplicate serial number when Philips re-programmed them, the FDA said. Serious risks...
On 14th June 2021, Philips Respironics issued a medical device recall notification (US only) and field-safety notice (International Markets) for mechanical ventilator devices including continuous positive airway pressure (CPAP), and bilevel positive airway pressure (bilevel PAP). This was in response...
In 2022, the FDA took the rare step of ordering Philips to step up its outreach to customers about the recall including "clearer information about the health risks of its products." At the time, the agency estimated only about half the people in the U.S. with affected machines knew they ...
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Optimal strategies to replace ventilators in children using home PPV‐T affected by the Philips recall are unknown. We conducted a retrospective study of children using home PPV‐T with recalled Trilogy ventilators who underwent inpatient ventilator change to non‐recalled portable home ventilators (PHV...