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
    57594
  • Event Risk Class
    Class 2
  • Event Number
    Z-2168-2011
  • Event Initiated Date
    2011-01-04
  • Event Date Posted
    2011-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96740
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Software: two displayed respiratory parameters are incorrect due to errors in the system software: mvalv (alveolar minute ventilation) and vt/kg (tidal volume/patient weight). in both instances, the displayed parameters are higher than actual.
  • Action
    Respironics issued Field Action Notification Letter via Fed'x on 1/4/11, notifying customers of the issue and to instruct them on conditions for continued use and return of the device. The device will be updated with revised software to correct the calculation errors. Any questions or need additional information about this recall action, Contact Respironics US Customer Service at 1-800-345-6443 for customers residing in the USA or +011 (203)697-6488 for International customers.

Device

Device Recall Philips
  • Model / Serial
    Serial Numbers: 167-000475 167-000496 175 235 236 237 238 239 240 356 376 389 414 483 502 510 511 686 693 700 723 724 725 612 146 155 171 173 and 178
  • Product Classification
    Anesthesiology Devices
  • Distribution
    Nationwide Foreign: Belgium, China, Columbia, Egypt, England, India, Italy, Saudi Arabia, and Spain
  • Product Description
    Philips FloTrak Elite modules: || FloTrak Elite P/N 1044971 || FloTrak Elite P/N 1051005 || NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations.
  • Manufacturer
    Respironics Novametrix, LLC.

Manufacturer

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