Devices

Respironics Recall of Trilogy Evo Ventilators

Philips Respironics has recalled (Class 1) its Trilogy Evo continuous ventilator devices due to a software issue that may cause a power malfunction. The product correction recall notifies customers to update the devices to the latest software version (1.05.06.00) to prevent “Battery Depleted” or “Loss of Power” alarms while sufficient power is still available, which could result in a sudden ventilation loss while the device alarms, a recall notice says. “All Trilogy Evo ventilators (Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300) are susceptible to this problem, except those ventilators with the software version 1.05.06.00 installed,” it says.

The notice says the device malfunction occurs only when all of the following conditions are met:

Software other than version 1.05.06.00 is installed on the ventilator,
The ventilator is operating in CPAP or PSV mode, and
The ventilator is not able to detect the respiratory effort of the patient for at least 10 minutes and 45 seconds.

The Trilogy ventilators use a microprocessor-controlled blower to provide pressure support, pressure control, or volume control during breathing support, according to the company. They are intended for individuals who require assistance with breathing and provide continuous or intermittent support.

To date, there have been no injury reports related to the issue, the notice says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome