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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 GE Healthcare Australia Pty Ltd
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