Events

Recall of Leica M525 F50/C50 Surgical Microscope with XY-Unit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Leica Microsystems (Schweiz) AG.

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
    15750
  • Event Initiated Date
    2013-12-19
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Pacific Dental Specialties Limited, 3 Clyde Road, Napier Hill, Napier 4110
  • Reason
    Leica microsystems (schweiz) ag has discovered that in certain activations of the xy, the system can continue to run laterally to its limit (run-on), but will stop if the surgeon activates any button., run-on of the xy can only occur in the rare situation of rapid consecutive activation on the 45°, 135°, 225°, or 315°. in addition, the run-on will stop if any other activation of the xy occurs.
  • Action
    Software to be upgraded

Device

Leica M525 F50/C50 Surgical Microscope with XY-Unit
  • Model / Serial
    Model: M525 F50 & M525 C50 with XY units, Affected: , Software version: Software versions prior to Pack D
  • Manufacturer
    Leica Microsystems (Schweiz) AG

Manufacturer

Leica Microsystems (Schweiz) AG