| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00679-1 |
| Product Name/Description |
GEHC Discovery NM/CT 670 Nuclear Medicine System
Model Number: 0910263223
ARTG Number: 200439 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare (HC) is aware of an incident in the United States, a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 where the equipment fell onto the patient during the scan. During the investigation, GE have identified a potentially related issue in connection with complaints reported to GEHC relating to the Discovery NM/CT 670 Nuclear Medicine System. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
While GE Healthcare continues the investigation, GE recommend that facilities immediately cease usage of the Discovery NM/CT system until additional precautionary actions can be performed. |
| Contact Information |
1300 722 229 - GE National Service and Support Centre |