Events

Recall of Device Recall Babylog 8000 plus with software version 5.n

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical, 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
    34391
  • Event Risk Class
    Class 2
  • Event Number
    Z-0515-06
  • Event Initiated Date
    2005-12-28
  • Event Date Posted
    2006-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43763
  • 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
    Failure to generate an alarm when an unintended disconnection occurrs.
  • Action
    Recalling firm has issued a medical device recall letter to consignees to the attention of the Director, Neonatal Intensive Care Unit via Certified Mail to alert them of additional monitoring requirements if a PEEP setting of less than 2.5 mbar is used

Device

Device Recall Babylog 8000 plus with software version 5.n
  • Model / Serial
    Catalog numbers 8418300, 8411162, 8418002, and 8418000
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was shipped to medical facilities nationwide
  • Product Description
    Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Manufacturer Address
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA