| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01149-1 |
| Product Name/Description |
ADAC ARGUS Gamma Camera Systems (Nuclear medicine system)
Serial numbers: A01100227 and 9807143
ARTG Number: 117642 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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 |
| Contact Information |
1800 251 400 - Philips Customer Care |