BEUDAMED
    FDA Recall Terminated

    Newport HT50 Ventilator (all Models)

    Recall: Z-1192-2007 · Initiated July 31, 2007

    Recall

    Recall Number
    Z-1192-2007
    Event Number
    38630
    Firm
    Newport Medical Instruments Inc
    FEI Number
    2023050
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 31, 2007
    Posted
    September 19, 2007
    Terminated
    March 21, 2012
    Address
    1620 Sunflower Ave, Costa Mesa, CA, 92626-1513

    Description

    Newport HT50 Ventilator (all Models)

    Reason

    Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not lasting as long as expected followed by ventilator shut down with less advance warning than when the battery was new.

    Action

    An Important Medical Device Correction Letter was issued on September 14, 2007 as a short term fix. The firm has submitted a long term correction as a supplement to its 510 K which is pending review by FDA.

    Distribution

    Worldwide including USA, Algeria, Argentina, Armenia, Australia, Belgium, Bolivia, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote D' Ivoire, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, England, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Liechtenstein, Lithuania, Malaysia, Mexico, Netherlands, New Caldonia, New Zealand, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Switzerland, Syria, Taiwan, Thailand, Turkey, UAE, Ukraine, United Kingdom, Venuzuela, Yemen, and Zambia

    Quantity

    8,160