Events

Recall of Carl Zeiss OPMI Pentero Surgical Microscope System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Carl Zeiss Meditec 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
    16308
  • Event Initiated Date
    2014-02-26
  • 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: Carl Zeiss (NZ) Ltd, 22 Fremlin Place, Avondale, Auckland 1026
  • Reason
    Based on post-market surveillance of hardware system performance, it has been identified that system components may cause, in rare situations, a blocking of the magnetic brakes or a system freeze/ system restart during operation potentially prolonging surgery.
  • Action
    Product to be modified

Device

Carl Zeiss OPMI Pentero Surgical Microscope System
  • Model / Serial
    Model: , Affected: Manufactured from December 8, 2006 to October 5, 2010
  • Manufacturer
    Carl Zeiss Meditec AG

Manufacturer

Carl Zeiss Meditec AG