| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00575-1 |
| Product Name/Description |
Natus Medical EEG Machines using Neuroworks v8.5 software
ARTG Number: 197550
(Life Healthcare Pty Ltd - Electroencephalograph) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
There have been multiple vulnerabilities discovered in Natus Neuroworks software, which is used in Natus Xtek EEG medical products. The vulnerable devices contain an ethernet connection for data acquisition and connection to networks. Under certain scenarios, these vulnerabilities allow a remote attacker to run arbitrary code on the device, including a denial of service attack. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Life Healthcare is advising that this issue is resolved in an updated software version - Neuroworks 8.5 GMA2. This software will be installed for users by Life Heathcare either on-site or via remote access depending on system setup.
This action has been closed out on 01/03/2019 |
| Contact Information |
02 8114 1500 - LifeHealthcare |