| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00971-1 |
| Product Name/Description |
IPS CaseDesigner Software
IPS CaseDesigner 2.2 for Windows 64-bit
IPS CaseDesigner 2.2 for MAC
IPS CaseDesigner 2.3 for Windows 64-bit
IPS CaseDesigner 2.3 for MAC
ARTG 300518
(Nobel Biocare Australia Pty Ltd - Dental treatment application software) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
KLS Martin Germany discovered internally an issue with the NHP (Natural Head Positioning) in IPS CaseDesigner. When adjusting the NHP by a large number of rotations (>15 rotation steps), the NHP adjustments suffer from a numerical instability and the visualisation is distorted. The issue is identified as a bug in the software. If not detected during the planning phase could lead to a longer surgery.
No clinical complaints or incidences were reported on this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Nobel Biocare advise that a new software release version will be made available in which the NHP adjustments are improved.
As soon as this new version is available and the software is started with an internet connection, a dialog will be shown requiring the user to download and update to this new version.
After download the installation process will be started which guides the user through the required steps. Administrator privileges are required during the installation of the new software version.
If you require any further information or support, please contact your local customer support representative at support.ips@klsmartin.com.
This action has been closed out on 30/01/2024 |
| Contact Information |
Customer support: support.ips@klsmartin.com. |