| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01321-1 |
| Product Name/Description |
Optima XR 220amx, Optima XR200amx with Digital Upgrade Mobile X-ray Systems
Model Numbers: 5555000-5, 5555000-6 and 5421698
ARTG Number: 201698 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/12/2013 |
| 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 mobile x-ray system 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/patient. If the user does not notice this change and continues to perform the exam, the images will be placed in an incorrect patient file. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users to pay close attention to the patient exam/entry selected from the worklist prior to selecting the Start Exam button to ensure that the system did not update and select an incorrect exam. GE Healthcare is providing a software upgrade to permanently correct the issue. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |