| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00121-1 |
| Product Name/Description |
Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (WDR1) (fluoroscopic x-ray system)
ARTG Number: 99423 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the WDR1 are not properly displayed. If the user continues to attempt to select one of the exams when this issue has occurred, the system will update the screen and in doing so, potentially select a different exam or patient. If the user does not notice this change and continues to perform the exam, the images will be placed in the incorrect patient file. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare are providing work around instructions for users to follow when using the WDR1 based systems for exams. Users should pay close attention to the patient exam/entry selected from the worklist prior to selecting the Start Exam button to ensure the system did not update and select an incorrect exam. GE is providing a software upgrade as a permanent fix. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |