A device meant to improve the outcomes of heart patients in life-threatening conditions is under fire from the FDA for its risk of puncturing the heart. Abiomed, a medical device manufacturer owned by Johnson & Johnson MedTech since 2022, is recalling instructions for using its…
A Florida woman died after being burned by a robotic device while undergoing colon cancer surgery, according to a new federal lawsuit. The suit alleges that a robotic device tore Sandra Sultzer’s small intestine during surgery, leading to complications that eventually resulted in her death.…
The litigation nightmare that has plagued medical device giant Philips Respironics for nearly two years isn’t over, despite a settlement agreement of at least $479 million finalized in September 2023. Philips recalled more than five million of its CPAP (continuous positive airway pressure) and BiPAP…
Two years ago, Philips Respironics was forced to recall millions of its machines designed to help patients with breathing issues. The products included ventilators, bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. CPAP lawsuits continue to…
Two years ago, while Americans were hoping the U.S. government would announce the end of the pandemic and their lives could return to normal, thousands of doctors and their patients were hit with an announcement of a different sort – devastating news from the Dutch…
The U.S. Food and Drug Administration (FDA) recently released updated information on medical device reports (MDRs) related to the major recall of thousands of Philips Respironics top-selling ventilators, BiPAP, and CPAP devices. The Philips machines are designed to assist sleep apnea patients who cannot continuously…
Philips Respironics, which issued a mass product recall on specific models of its sleep apnea machines and ventilators in June 2021, recently concluded its first round of post-recall safety testing. CPAP (continuous positive airway pressure) and BiPAP (bilevel positive airway pressure) machines are medical devices…
Last summer, Philips Respironics made a startling announcement. Some of the company’s medical devices had flaws that could expose patients to carcinogenic chemicals. The FDA recalled several Philips CPAP machines, ventilators, and BiPAP machines. After a recall, a manufacturer typically offers a repair, refund, or…
Problems continue to grow for Philips Respironics, the internationally-known maker of breathing devices with headquarters in Pennsylvania. In June of 2021, the company was forced to recall more than five million continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines due to…
On September 6, 2022, the FDA issued a recall regarding certain Philips Respironics devices. Masks used with bilevel positive airway pressures (BiLevel PAP, BiPAP or BPAP) and CPAP machines may pose a serious safety concern to those using the devices. It is estimated that more…