| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00696-1 |
| Product Name/Description |
Sense, Sight Monitoring Hub and Monitoring Portal (part of Seer Home) medical devices.
Sense
Product Code: SM-01-8001
Serial numbers: Multiple
Sight Monitoring Hub
Product Code: SM-03-8001
Serial numbers: Multiple
Monitoring Portal
Product code: Monitoring Portal
Lot number: 2.1.1-rc.1
Serial numbers of iPads where Monitoring Portal is installed: Multiple
ARTG 340038
(Seer Medical Pty Ltd - Electroencephalographic long-term ambulatory recorder) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
Seer Medical is informing of a non-compliance with Electromagnetic Compatibility (EMC) testing according to IEC-60601-1-2.
The Devices were manufactured and distributed without application of proper design change and manufacturing controls and were distributed with labelling deficiencies.
The potential risk to health from emissions is interference with other medical devices.
The quality of the data that has been collected during vEEG studies is not affected by this recall, and all completed study data will remain available on Seer Cloud. |
| Recall Action |
Recall |
| Recall Action Instructions |
Actions for customers:
- Ongoing studies with patients who do not have implantable or wearable medical devices that may be susceptible to electrical interference may complete their study.
- Patients with studies scheduled within the next 5 business days of this recall notice may proceed with their study provided that they have no implantable or wearable medical devices.
- Any vEEG studies with patients that have implanted, or wearable medical devices should be halted immediately.
- On the 6th business day following this recall notice, and when patients return devices from ongoing studies:
· Inspect stock immediately & quarantine affected stock on hand to prevent further use.
· Seer Medical will contact you to arrange pick up of the affected stock.
No alternative stock is available. Any studies that are scheduled later than 5 business days after receiving this recall notification should be cancelled or moved to other technologies. |
| Contact Information |
1300 869 888 - recalls@seermedical.com - Seer Medical Holdings Limited |