Events

Recall of Device Recall PLV100 Portable Lifecare Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics, 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
    48980
  • Event Risk Class
    Class 2
  • Event Number
    Z-2344-2008
  • Event Initiated Date
    2008-07-08
  • Event Date Posted
    2008-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72445
  • 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
    Certain plv-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure.
  • Action
    The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/8/08. The letter informed the customer of the problem and the need to contact the firm for a replacement. Contact Respironics Customer Service at 1-877-387-331 for assistance.

Device

Device Recall PLV100 Portable Lifecare Ventilator
  • Model / Serial
    Model/Catalog number PLV-100. Circuit board part numbers 1034786 version 5 or 1036038 version 3
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution ---USA: NC, IL, NJ, MO, TX , OH, IA, and OK and countries of Japan, Denmark, Korea, Australia, Finland, Canada, Argentina, New Zealand, Hong Kong, and India.
  • Product Description
    PLV-100 Portable Lifecare Ventilator Life support ventilation || The device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Life support ventilation
  • Manufacturer
    Respironics, Inc.

Manufacturer

Respironics, Inc.
  • Manufacturer Address
    Respironics, Inc., 1001 Murry Ridge Ln, Murrysville PA 15668-8550
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA