| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01459-1 |
| Product Name/Description |
Sensis, Sensis Vibe Hemo, Sensis Vibe Combo with VD12A software
UDI-DI : 4056869010137, 4056869010199, 4056869010205
ARTG 273953
(Siemens Healthcare Pty Ltd - Computer, cardiac catheterization laboratory) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/11/2022 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified four potential issues with Sensis/Sensis Vibe systems:
Issue 1: “PASSWORD STORE CORRUPTED” error message during system bootup;
Issue 2: Subsystem crash during examination;
Issue 3: Dialog Monitor Computer (DMC) application crash while loading a study;
Issue 4: Software crash due to system internal timeout
The potential high risks associated to the issue are the procedure might be delayed or the operation needs to be cancelled. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens are advising customers that they will be contacted by Siemens to schedule time for a software update to correct the issues. Customers can also contact Siemens service organisation for an early appointment.
Customers are also advised to follow interim actions outlined in the customer letter (will be provided only to the impacted customers by Siemens).
Customers are informed that it is not necessary to re-examine any patients in relation to the issues. |
| Contact Information |
1800 310 300 - Customer Care Center - Siemens |