| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00198-1 |
| Product Name/Description |
Advantx Legacy/Legacy-D Radiographic and Fluoroscopic System
ARTG Number: 99423 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
There have been reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator. There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare will correct all affected products and a GE Healthcare representative will contact affected customers to arrange for the correction. In the interim, customers are advised to check the table tub bottom pan and patient step hardware for any looseness. Discontinue use of the patient step in case of any looseness and immediately contact the GE service representative.
This action has been closed-out on 1/03/2018. |
| Contact Information |
1800 659 465 - GE National Call Centre |