Events

Recall of Device Recall KION

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet 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
    31054
  • Event Risk Class
    Class 2
  • Event Number
    Z-0710-05
  • Event Initiated Date
    2005-01-11
  • Event Date Posted
    2005-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37072
  • 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
    Mixer, Breathing Gases, Anesthesia Inhalation - Product Code BZR
  • Reason
    Software update so us customers will be updated equally with worldwide customers. ver. 5.0 will be upgraded to ver 7.0. quality will improve and enhance functionality.
  • Action
    MCC has assigned an internal task team to manage plan and perform the correction ofthe installed base of KION (intended for clinical use) in US. Updates started on January 11, 2005.

Device

Device Recall KION
  • Model / Serial
    Serial Number: 2034; 3416; 3417; 3418; 3419; 3420; 3027; 0501; 3394; 3395; 3396; 3433; 3444; 3445; 3446; 2355; 2356; 2033; 2035; 1838; 1839; 1840; 1841; 1842; 1873; 1874; 1875; 1876; 1877; 1899; 1900; 1902; 1903; 2132; 2032; 1723; 1724; 1725; 1726; 1727.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The systems were distributed to hospitals throughout the nation.
  • Product Description
    KION Anesthesia System.
  • Manufacturer
    Maquet Inc

Manufacturer

Maquet Inc
  • Manufacturer Address
    Maquet Inc, 1140 Route 22 East, Bridgewater NJ 08807-2912
  • Source
    USFDA