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

    ‘Electronic tongues’ may help diagnose early stage bladder cancer

    New research presents a complex electronic device as a possible new, efficient, simple, and cost-effective way of detecting bladder cancer in its early stages and monitoring people living with bladder cancer. In a quest to find a better way of diagnosing bladder cancer, Spain-based researchers from the Polytechnic University of Valencia (UPV), the La Fe …

  •
    21 febrero, 2020

    COFEPRIS Challenges 2020

    Since December 1st, 2018 a historical change in administration that consisted of a new president who is committed to Public Office cleansing of corrupt and unequal practices had a strong impact on the whole country course of operation. Many institutions were eliminated or were audited and restructured.  Cofepris was audited and analyzed for permanence or …

  •
    18 junio, 2019

    Stroke significantly increases the risk of dementia

    In the largest study of its kind, researchers conclude that stroke doubles the risk that an individual will eventually develop dementia. If you want to read more about this news click here.