| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00284-1 |
| Product Name/Description |
StealthStation S8 Application
Software name: SW APP 9735762 STEALTH S8 APP
Model number: 9735762
Version: 1.0.1, 1.0.2, 1.0.3, 1.1.0, 1.2.0
ARTG 126293
(Medtronic Australasia Pty Ltd - Stereotactic surgery system, multi-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
An anomaly related to the loss of text and numerical characters in the banner(s) of the software application impacts the cranial procedures within StealthStation S8 Application, versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1. The software anomaly can cause numbers or letters to be ‘missing’ from the displayed text and to be replaced by a space instead in the 'Distance to Target' and 'Tip Stop Point' areas. All other navigation information on the screen is accurate, including active navigation images.
This anomaly is corrected in software version 1.3.0 and all subsequent versions. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A Medtronic Field Representatives will contact affected customers and schedule visits to complete the software update. |
| Contact Information |
0456 995 887 - Matthew Greig, Cranial and Spinal Technologies |