Events

Recall of Device Recall Ventilator, continuous, lifesupporting; Ventilator, continuous, facility use

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

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
    73177
  • Event Risk Class
    Class 2
  • Event Number
    Z-1065-2016
  • Event Initiated Date
    2016-01-18
  • Event Date Posted
    2016-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143322
  • 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
    Software issue.
  • Action
    Philips Respironics has determined that affected devices may continue to be used in accordance with the device Instructions for Use and the Field Safety Notification that is being issued to customers. Philips Respironics will be providing a software update for affected devices free of charge. Customers will be notified by mail when the software update is available for download. For further questions please call ( 724 ) 387-7500.

Device

Device Recall Ventilator, continuous, lifesupporting; Ventilator, continuous, facility use
  • Model / Serial
    11 digit S/N begginning with GV or TV; also TGY1D01463
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.
  • Product Description
    Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, || Trilogy EC, Garbin, Garbin Plus || Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
  • Manufacturer
    Philips Respironics

Manufacturer

Philips Respironics
  • Manufacturer Address
    Philips Respironics, 1740 Golden Mile Hwy, Monroeville PA 15146-2012
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA