The Magazine for Sleep Professionals
Thursday, September 10, 2026
Nihon Kohden OrangeMed, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NKV-330 Ventilator System. The NKV-330 is a non-invasive ventilator that provides respiratory support to adult and pediatric patients. It offers not only non-invasive ventilation but also invasive ventilation as well as high-flow oxygen therapy. In […]
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Puritan Bennett 980 Series Ventilator Model Numbers: See Recall Database Entries Distribution Dates: February 23, 2017 to April 4, 2020 […]
The national plaintiffs’ law firm Berger Montague has filed a class action lawsuit against Dutch medical equipment company Philips to protect consumers harmed by Philips’ recalled sleep apnea machines, including CPAP and BiPAP machines, and ventilators, which may increase users’ risk of cancer and pulmonary fibrosis, and cause other injuries […]
Following the company update on April 26, 2021, Royal Philips has provided an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component […]
Fitbit has developed a high-quality, low-cost, easy-to-use emergency ventilator, Fitbit Flow, which has obtained Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for use during the COVID-19 public health emergency. After seeing the global need for ventilators, Fitbit applied its deep in-house expertise in advanced sensor development […]
Mexico has welcomed a planeload of Hamilton Medical ventilators from the US to help treat Covid-19 patients, says Mexican Foreign Minister Marcelo Ebrard. The 211 machines were purchased following an informal agreement between the neighboring nations’ leaders in mid-April. Last week, several hospitals in Mexico City said they were turning […]
Senior British doctors have warned that 250 ventilators the United Kingdom bought from China risk causing “significant patient harm, including death,” if they are used in hospitals, according to a letter seen by NBC News. The doctors said the machines had a problematic oxygen supply, could not be cleaned properly, […]
Xerox Holdings Corporation and Vortran Medical Technology are teaming up to speed and scale production of Vortran’s GO2Vent ventilator and related Airway Pressure Monitor (APM-Plus) for hospitals and emergency response units fighting the battle against COVID-19. The two companies expect to work together to quickly respond to the shortage of […]
Dyson, the British vacuum maker known for its technologically advanced and wildly expensive household products, has received an order from the UK government for 10,000 ventilators to support efforts by the country’s National Health Service to treat coronavirus patients. James Dyson, the company’s billionaire founder, confirmed the order in a […]
Nihon Kohden has debuted its NKV-550 Series Ventilator System, which offers a full suite of applications necessary in a critical care setting for neonates through adults. The ventilator features an integrated touchscreen, intuitive user interface, and on-screen help functions. The NKV-550 was developed to seamlessly transition between invasive ventilation, noninvasive ventilation and high-flow oxygen therapy, […]
