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