Events

Recall of Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting surgical microscopes)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Leica Microsystems Pty Ltd.

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
    RC-2013-RN-00935-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00935-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Leica microsystems is notifying their customers of an important safety issue concerning the ceiling supply units csu 80xx/ csu 60xx, manufactured from 1997 - 2003. the ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. as a result, the lift arm fell down approximately 60 cm (23.6 inches).
  • Action
    Leica Microsystems is contacting their customers to arrange for the complete inspection of the ceiling mount and is providing customers with additional preventative maintenance protocols.

Device

Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting surgical microscopes)
  • Model / Serial
    Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting surgical microscopes)Leica Ceiling Mount MSF-1Art. Numbers: 10446781 & 10446782Leica Ceiling Mount MS-1F & MC-1FArt. Numbers: 10446657 & 10446658ARTG Number: 137683
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd