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Recall of Newport e360 Ventilator
  • Type of Event
    Recall
  • Event ID
    58620
  • Event Risk Class
    Class 2
  • Event Number
    Z-2468-2011
  • Event Initiated Date
    2009-10-27
  • Event Date Posted
    2011-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99720
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • Reason
    Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.
  • Action
    Newport Medical Instruments Inc. initiated a field correction on October 27, 2009, to address complaints received regarding e360 ventilators that were shipped with a different software version from what the customers ordered. Newport Medical Instruments provided the correct software to the Newport sales or service providers who were responsible for the units affected. They installed the correct software into the ventilators at the customer sites. No written Correction Notice was provided since the corrections were done at the customers' request. Should you have any questions or require additional information, please call (714) 427-5811 extension 344.