| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00573-1 |
| Product Name/Description |
All Precision 500D Radiographic and Fluoroscopic (R&F) Systems and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic (R&F) Systems
ARTG Number: 99423 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
The Spot Film Device (SFD)/ Intelligent Digital Device (IDD) safety mechanism installed on the above systems may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1” (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator. There have been no reported injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare will correct all affected products. A GE Healthcare representative will contact you to arrange for the correction.
The system can continue to be used provided end users:
- Perform preventative maintenance in accordance with your product labeling. This includes inspection of the counterweight cables and pulleys every 6 month, and replacement of the counterweight cables every four years.
- Set the manual Myelographic stop on the fluoroscopy carriage during exams. This action has been closed-out on 05/08/2016. |
| Contact Information |
1800 659 465 - National Call Centre |