| TGA Action ID |
RC-2026-RN-00585-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
LATITUDE Clarity Server Software
Model Number: 7248
GTIN: 00802526613852 |
| ARTG Number |
411053 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is a potential for a delay in AF Burden Alert notification affecting the LATITUDE Clarity server software which supports the LUX-Dx family of ICMs.
This delayed AF Burden Alert notification behaviour by LATITUDE Clarity may occur if the Alert for AF Burden = Threshold is configured to ">0 hours per day" setting (a non-default configuration).
Boston Scientific has received one complaint globally related to this delayed notification behaviour with no patient injuries or deaths reported. |
| Instructions for Customers/Users |
A server software update is planned to correct this behavior.
Until updated server software is available, customers should consider the following options:
1. Change Threshold for AF Burden Alert Setting
2. Enable AF Events Alert with Minimum Duration
3. If Unchanged, Potential Delay in AF Burden Alert Notification
The customer letter has instructions for each of these options.
NB: Boston Scientific does not recommend replacement of the implanted ICM. |
| Action Commencement Date |
3/08/2026 |
| Responsible Entity |
|
| Contact Information |
02 8063 8299 Technical Services or ANZ_Incident_Report@bsci.com |