Events

Safety Alert for adac argus gamma camera systems

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips Medical Systems Cleveland Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-11-11
  • Event Date Posted
    2013-11-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131111.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: philips adac argus gamma camera systems the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning adac argus gamma camera systems manufactured by philips medical systems cleveland inc. products with serial numbers a01100227 and 9807143 are affected. a recent investigation has determined that visual inspections of the fork joints behind the detector that is conducted during six month preventive maintenance 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 when the weldment fails. philips is informing the customers to immediately cease the use of the affected systems. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01149-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 november 2013.

Device

adac argus gamma camera systems

Manufacturer

Philips Medical Systems Cleveland Inc
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH