| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00434-1 |
| Product Name/Description |
BeneHeart C-Series Automated External Defibrillator
Multiple Serial Numbers and Product Codes
ARTG166368
(Mindray Medical Australia Pty Ltd - Non-rechargeable public automated external defibrillator) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Mindray has identified that certain BeneHeart C Series Automated External Defibrillator may have incorrectly functioning configurations (the patient button type is failing, an incorrect CPR time or energy sequence is changed to a non-default sequence) that may not provide the required patient defibrillation therapy.
To date, Mindray has not received any reports of serious incidents such as death or serious injury due to the above problem. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Upon receipt of this notice, please Inspect your stock immediately, quarantine and discontinue use of the affected device.
Please contact the Mindray service team and they we will organise a software repair for the problem as soon as possible.
If you have supplied or transferred any potentially affected product to another facility or organisation, provide that facility with a copy of this letter immediately. |
| Contact Information |
1800793011 or info.au@mindray.com |