Events

Recall of Device Recall Newport HT50

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Newport Medical Instruments Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38630
  • Event Risk Class
    Class 2
  • Event Number
    Z-1192-2007
  • Event Initiated Date
    2007-07-31
  • Event Date Posted
    2007-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54060
  • 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 - Product Code CBK
  • 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.

Device

Device Recall Newport HT50
  • Model / Serial
    All models, all serial numbers
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    Newport HT50 Ventilator (all Models)
  • Manufacturer
    Newport Medical Instruments Inc

Manufacturer

Newport Medical Instruments Inc
  • Manufacturer Address
    Newport Medical Instruments Inc, 1620 Sunflower Ave, Costa Mesa CA 92626-1513
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA