| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00636-1 |
| Product Name/Description |
Vocera Platform
Versions affected: 6.0.x – 6.4.0.38
ARTG 321081
(Stryker Australia Pty Ltd- Alarm, software) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
1/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
After adding groups in test environment to existing alert groups, the new groups did not receive the alert unless these groups were removed and added a second time. The members of tertiary subgroups were being disassociated with the primary parent group, when a secondary subgroup was removed from the primary parent group.
When configured with medical device alarms, affected groups may not receive alarms. This would largely result in user annoyance and dissatisfaction.
This action was undertaken prior to TGA notification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
There are no customer actions required. A support case was assigned to each customers’ Designated Support Contact (DSC) and Vocera Support has worked with the DSC to install the software update to production environments. All support cases have been closed.
This action has been finalised on 6/8/2024. |
| Contact Information |
0439 661 638 - Samantha Holland (Post Market Associate) |