| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00767-1 |
| Product Name/Description |
Seer App: Epilepsy Management
Software version numbers: 4.1.0, 4.1.1, 5.0.0, 5.0.1, 5.1.0
ARTG 351753
(Seer Medical Pty Ltd - Self-care monitoring web-based application software) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
Seer Medical identified insufficient validation data to support the accuracy, usability and functionality of the Seizure Cycles feature within the App. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to discontinue use of the seizure cycle function, part of the Seer App: Epilepsy Management.
Other features of the Seer App, such as the medication reminder, seizure diary and summary report, are not affected and will remain available for use.
The seizure cycle feature will not longer be available and there is no current timeline for reinstatement of this feature. |
| Contact Information |
Seer Medical Holdings Limited - 1300 869 888 - recalls@seermedical.com |