The FDA issued a notice updating instructions for a number of ventilators made by Philips (NYSE:PHG) Respironics. This recall involves updating instructions for devices, not removing them from use or sale. The FDA identified the recall as the most serious kind, as it may cause serious injury or death. It relates to an October warning […]
Philips Respironics
Philips to pay $25M to monitor people affected by CPAPs recall
A federal judge recently approved Philips paying $25 million to monitor and research the affects of its major respiratory devices recall. The monitoring will occur over the next 15 years, according to the settlement approved Oct. 31 by U.S. District Judge Joy Flowers Conti in western Pennsylvania. Conti is overseeing all federal lawsuits involving the […]
Philips warns on Trilogy ventilator nebulizers following recall
Philips Respironics has issued additional usage instructions as part of a voluntary recall of some of its ventilators. Last week, the FDA designated a recall of Trilogy Evo, Trilogy EV300, Trilogy Evo O2, Trilogy Evo Universal ventilators as Class I, the most serious kind. The issue centered around software errors, including an inaccurate display of […]
Philips has another Class I level ventilator recall
Philips continues to have serious respiratory device recalls, more than three years into a major safety crisis for its Respironics business. Yesterday, the FDA designated a recall of Trilogy Evo, Trilogy EV300, Trilogy Evo O2, Trilogy Evo Universal ventilators as Class I, it’s most serious level. Philips says the action involves roughly 90,000 units worldwide, […]
FDA corrects death tally in Philips ventilator recall
The FDA issued a clarification that significantly trims the number of deaths reportedly associated with a recall of Philips Respironics ventilators. On June 28, the FDA issued a Class I recall notice involving potential Ventilator Inoperative alarm failures on BiPAP V30, BiPAP A30, BiPAP A40 devices. At the time, the FDA cited 952 reports of […]
Philips is downsizing Respironics operations in Pennsylvania
Royal Philips (NYSE: PHG) announced this week that it is shuttering its Respironics business’ Pittsburgh headquarters and slashing hundreds of manufacturing jobs in the region. In a statement shared with local media, the Dutch medtech giant said it will exit its headquarters building in Bakery Square in Pittsburgh, moving 500 jobs to nearby facilities in […]
How Philips’ significant respiratory devices recall unfolded
There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline. Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could […]
Philips warns on more BiPAP ventilators in Europe, reports 7 deaths related to issue
Philips issued an urgent field safety notice in Europe to warn of issues with some of its bi-level positive airway pressure (BiPAP) ventilators. The company’s notice said it received 888 complaints regarding interruptions and/or loss of therapy with several BiPAP devices. The list includes the BiPAP A30, A30 EFL, A30 Hybrid, A40, A40 EFL and […]
Philips stock skyrockets on positive outlook, $1.1B Respironics settlement in spite of Q1 misses
Philips shares got a huge boost today despite first-quarter results that fell shy of the consensus forecast on Wall Street. Investors appeared to react positively to recent updates on the company’s long-running Respironics recall. Shares of PHG rose more than 35% to $28.50 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes […]
Philips gets judge’s OK to settle Respironics recall economic losses
Philips will pay at least $613 million to settle economic lawsuits related to its recall of millions of CPAPs and other respiratory devices. U.S. District Court Judge Joy Flowers Conti, who has been overseeing the multidistrict litigation out of her court in Western Pennsylvania, approved the final settlement yesterday. “The amount of value created and […]
Philips comes to consent decree agreement with DOJ, FDA over Respironics recall
Philips today announced a final agreement on a consent decree with the FDA and U.S. Dept. of Justice (DOJ). The consent decree primarily focuses on its Philips’ Pennsylvania-based Respironics business — the subject of a major recall over the past several years. That includes manufacturing facilities in Murrysville and New Kensington, a service center in […]
