| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00131-1 |
| Product Name/Description |
NX workstation with NX 3.0.8950 image processing software
ARTG Numbers: 119463, 173861, 178856 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Due to a memory issue, users are shown a warning message about unexpected error and possible incorrect data integrity. A reboot of the workstation computer after having received the warning message prevents the issue from occurring. At this stage, there has been one instance whereby the warning instructions were not followed and resulted in the image of one patient being archived in another patient’s record. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In order to prevent this issue, Agfa HealthCare is advising users to conduct a daily reboot of their workstation by completely turning off the computer and then restarting it. Users are further advised to follow all warning instructions as indicated on their NX workstation and reboot the workstation’s computer if a warning message appears. A new version of the NX software (3.0.9000) will be released shortly and users will receive this upgrade to their installations accordingly.
This action has been closed out on the 12/10/2018. |
| Contact Information |
1300 364 612 - Agfa Healthcare Help Desk |