Events

Recall of Device Recall Philips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics Novametrix, LLC..

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
    59312
  • Event Risk Class
    Class 2
  • Event Number
    Z-3288-2011
  • Event Initiated Date
    2011-07-29
  • Event Date Posted
    2011-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102225
  • 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
    Spirometer, monitoring (w/wo alarm) - Product Code BZK
  • Reason
    Pressure lines maybe occluded and display incorrect tidal volumes.
  • Action
    Respironics Novametrix, LLC on July 29, 2011 notified accounts via e-mail or tracked receipt, an Urgent - Medical Device Recall letter to notify customers of the issue and to instruct them on conditions for continued use. Monitors will need to be returned for functional performance testing at their facility. Customers can contact Respironics US Customer Service at 1-877-387-3311 for customers residing in the USA or +011 (203)697-6348 for International customers, if they have any questions or need additional information.

Device

Device Recall Philips
  • Model / Serial
    Serial Numbers 525 539 146 155 171 173 178 611 612 150 165 231 234 175 235 236 237 238 239 240 356 376 389 414 000475 483 000496 502 510 511 686 693 700 723 724 725 167-000385 167-000487 232 000372, and 000834.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.
  • Product Description
    FloTrak Elite modules || FloTrak Elite P/N 1044971 || FloTrak Elite P/N 1051005
  • Manufacturer
    Respironics Novametrix, LLC.

Manufacturer

Respironics Novametrix, LLC.
  • Manufacturer Address
    Respironics Novametrix, LLC., 5 Technology Dr, Wallingford CT 06492-1942
  • Source
    USFDA