| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00741-1 |
| Product Name/Description |
Rotaflow II System - Serial interface cable
Lot Number: 3000289870
ARTG 179104
(Getinge Australia Pty Ltd - Heart-lung bypass system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
RS232 cable of the Rotaflow II does not comply with the IEC 60601-1 standard as the capacitor of the respective socket is designed for 300V rather than 500V AC required by the IEC 60601-1. When the required voltage was applied, the RS232 cable was damaged as a result. In the worst-case scenario, 17 mA could flow through the user's body this way (electrical shock through body). |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
- Quarantine and return immediately all affected products in their inventory to their local Getinge representative.
- Upon return of the affected products, contact their local Getinge representative for credit. |
| Contact Information |
1800 438 464 - Getinge Customer Service |