Events

Recall of OPMI Pentero surgical microscope system (PC 2.1)Manufactured from December 8, 2006 to October 5, 2010

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Carl Zeiss 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-2014-RN-00174-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00174-1
  • 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
    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
    Carl Zeiss is providing a software and hardware update to ensure the malfunction does not occur. An enhanced long-term software and hardware maintenance of the OPMI Pentero system procedure is also included in the maintenance package. This action has been closed-out on 28/01/2016

Device

OPMI Pentero surgical microscope system (PC 2.1)Manufactured from December 8, 2006 to October 5, ...
  • Model / Serial
    OPMI Pentero surgical microscope system (PC 2.1)Manufactured from December 8, 2006 to October 5, 2010Serial Numbers: 6631402471 to 6631461774ARTG Number: 187127
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd