| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00089-1 |
| Product Name/Description |
Samaritan PDU 400 (automated external defibrillator)
Serial Numbers between 08P00001003 to 11P00007347 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
The software of Samaritan PDU 400 devices may fail to accurately determine the remaining capacity of the device battery. Rather than emitting an alarm warning the user that the device has insufficient battery to deliver therapy the device may shut down. In such circumstances, an affected device may be unable to operate during a sudden cardiac arrest.
This action was undertaken prior to the agreement of the communication by the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Areo Healthcare provided replacement PDU 400 devices to all affected customers. |
| Contact Information |
1800 628 881 - Aero Healthcare |