Events

Recall of ADAC ARGUS Gamma Camera Systems (Nuclear medicine system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-01149-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01149-1
  • 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
    A recent investigation has determined that visual inspections of the fork joints behind the detector that is conducted during six month preventive maintenance (pm) may not detect small cracks or deficiencies in the fork weldment. a failure in the fork weldment has the potential to cause the detector assembly to detach, resulting in serious injury or death to a patient, operator or service personnel member if he or she is in the direct path of the detector assembly and the weldment fails.
  • Action
    Philips Electronics Australia is informing the customers to immediately cease the use of the affected systems. The manufacturer is currently undertaking further analysis regarding the issue and there will be further communication to the customers relating to the corrective action, once the investigation is finalised. This action has been closed-out on 29/01/2016

Device

ADAC ARGUS Gamma Camera Systems (Nuclear medicine system)

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA