Events

Recall of Draeger Movita 603x/DVE 803x Ceiling Supply Unit

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
    66537
  • Event Risk Class
    Class 2
  • Event Number
    Z-0282-2014
  • Event Date Posted
    2013-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122561
  • 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
    Table, operating-room, ac-powered - Product Code FQO
  • Reason
    Cases were encountered with the draeger movita 603x/dve 803x ceiling supply units where the drive screw in the motor unit broke and the lift arm fell down approximately 60 cm (23.6 inches).
  • Action
    An "Urgent Medical Device Recall" notification letter was sent to users in September 2013. The issue was described and recommended actions were provided. Customers may contact (800) 543-5047 and select 1, then 2.

Device

Draeger Movita 603x/DVE 803x Ceiling Supply Unit
  • Model / Serial
    Catalog numbers:MZ00614, MZ01038, MZ02190, MZ02254, and MZ02332
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (Nationwide)and in the country of Canada. (note: the ceiling supply units are not classified as a medical device by Health Canada).
  • Product Description
    Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
  • 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