Post market surveillance data received by Philips Respironics indicate that these devices, which were remediated and now contain new foam, could experience a malfunction.
Problems Reported with Recalled Philips Ventilators, BiPAP …
In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP …
Ventilator recall issued with warning of "serious injuries or death"
May 15, 2024 · "Please be aware, this recall is a correction, not a product removal. Philips Respironics is providing a software update for its Trilogy Evo continuous ventilators," the FDA …
Philips Respironics Trilogy Evo Ventilator Recall Identified as Class I
May 13, 2024 · FDA today identified Philips Respironics Trilogy Evo continuous ventilator recall as Class I, over a month after the company initiated the voluntary correction in March.
The Philips Respironics Recall of Ventilators and Positive Airway ...
Nov 14, 2022 · Guidance from the International Organization for Standardization (ISO) figures prominently in developing medical devices and FDA surveillance of safety.
Philips : Respironics field action – FAQ – October 23, 2023
Oct 23, 2023 · As part of its post market surveillance activities, Philips Respironics received and continues to receive device associated complaints that have subsequently been filed by …
Analyzing FDA data related to breathing machine recall
Dec 7, 2023 · The Pittsburgh Post-Gazette and ProPublica analyzed more than 2 million complaints about medical device malfunctions, patient injuries and deaths submitted to the …
Philips leaving the United States: what does that mean for
Aug 1, 2024 · What does the withdrawal of Philips Respironics from the US market mean for physicians and patient care teams? Given the challenges over the past 2 years with limited …
Post market surveillance data received by Philips Respironics indicate that these devices, which were remediated and now contain new foam, could experience a malfunction.
Active Philips Respironics Field Service Actions
Post market surveillance data received by Philips Respironics indicate that these devices, which were remediated and now contain new foam, could experience a malfunction. This issue does …