ResMed ventilators recall is Class I

By

FDA today designated a ResMed (NYSE:RMD) recall of certain Stellar non-invasive and invasive ventilators as Class I — the agency’s most serious level.

The sound alarm on the ventilators may not work if the device has a failed electronic part, is stored without AC power for more than 36 hours, or powers on automatically when connected to AC power without pressing the power switch, according to FDA.

Read more.

 

 

Posted in News.
Share

Deja una respuesta

Tu dirección de correo electrónico no será publicada.

Related Posts

  •
    18 junio, 2019

    New York Times calls for tightened medical device regulation from FDA

    The New York Times last Friday released an editorial calling for improved regulation on medical devices from the FDA, citing a number of recent controversial devices that have made headlines for injuries and deaths related to their use.  If you want to read more about this news click here.

  •
    10 octubre, 2019

    Medtronic announces Infuse spine trial

    Medtronic (NYSE:MDT) said today that it won FDA approval for a clinical trial of its Infuse bone graft in transforaminal lumbar interbody fusion spine procedures. The Minneapolis-based company started recruiting for the prospective, randomized pivotal trial, which is slated to enroll up to 1,000 patients. The TLIF trial would be the second clinical trial for Infuse, …

  •
    10 octubre, 2019

    Study: Abbott, Edwards may have mislabeled hundreds of patient deaths

    Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA Internal Medicine editor Dr. Rita Redberg, former FDA unique device identification (UDI) external program manager Madris Tomes and others examined a total …

  •
    30 diciembre, 2019

    Finding a non-invasive way to predict effectiveness of cancer therapy.

    «Researchers have taken a critical step toward developing a non-invasive nuclear medicine technique that can predict the effectiveness of therapy for cancerous tumors, allowing for personalized, precision treatment.» Read more.