Events

Recall of Device Recall Draeger

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical Systems, 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
    67056
  • Event Risk Class
    Class 2
  • Event Number
    Z-0714-2014
  • Event Initiated Date
    2013-12-10
  • Event Date Posted
    2014-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124627
  • 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
    Monitor, physiological, patient (with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    After a test in which a low spo2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening spo2 alarm (red) did not activate when the spo2 values were decreased to reach the red alarm limit.
  • Action
    An Urgent Medical Device Recall Letter, dated December 2013, was sent to Users. Once available Drager will update components of the IACS Monitoring Solution System.

Device

Device Recall Draeger
  • Model / Serial
    with software versions VG2.0.3 and higher.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
  • Product Description
    Draeger Infinity Acute Care System Monitoring Solution
  • Manufacturer
    Draeger Medical Systems, Inc.

Manufacturer

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