| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00921-1 |
| Product Name/Description |
Interventional Angiography System
Product codes: INFX8000C; INFX-8000V
ARTG 94739
(Canon Medical Systems ANZ Pty Ltd X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
If the SPOT fluoro mode is activated, and the user changes the location of the ROI from the default position then changes the acquisition program, the collimator blades will return to the default position, whilst the display indicates no change.
In the case when the acquisition program is changed the displayed SPOT Fluoro x-ray exposure may be partially covered by the static image. This may lead to unintentional X-ray exposure to the region outside the selected ROI. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A software update is being developed to correct the problem. Customers will be contacted when it is available.
Until the software update is available customers are advised to not use the Spot Fluoro function. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used. |
| Contact Information |
1300 655 155 - Canon Medical Systems ANZ |