| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00799-1 |
| Product Name/Description |
Enterprise Imaging XERO Viewer
UDI-DI: 05400874000710
All versions
ARTG 269664
(AGFA HealthCare Australia - Radiology picture archiving and communication system application software) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
A coding error has been identified in the initialisation of pixel spacing in the XERO Viewer.
When an image has non-square pixel spacing, the reference/localiser line is incorrectly placed on the scout image in the XERO Viewer (offset from actual position).
When viewing a CT localiser radiograph, also known as a scanogram or scout image in the sagittal plane next to an axial series, the localiser/scout line or the active target localisation tool may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location.
This problem only applies to XERO Viewer. It does not apply to the XERO Viewer Extended Tools (Xtend) component or the Enterprise Imaging Diagnostic Desktop Viewer.
Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
AGFA HealthCare will provide the software corrections for the affected versions. A patch is available for each of the following XERO Viewer version streams:
- 8.4.x
- 8.3.x
- 8.2.x
- 8.1.4.x
- 8.1.2.x
A Support organisation representative will contact all customers on any of these versions and coordinate the correction activity. The patch installation will not require any downtime.
For versions of XERO Viewer prior to 8.1.2, the problem can be prevented from happening at your site by:
- Using the XERO Viewer Extended Tools component (Xtend), if enabled.
- Using the Enterprise Imaging Desktops viewer.
- There is an option to disable the features affected by this problem. This can be configured by the administrator via AGFA Support.
This action has been finalised on 24/10/2024. |
| Contact Information |
0413 055 842 Geoff Leggo |