| TGA Action ID |
RC-2026-RN-00103-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Cardiosave - Battery Charging Stations
Item Number: D998-00-0802
Serial Number: 210022344EAI |
| ARTG Number |
118266 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The Battery Charging Station is an optional dual-bay charger used to charge the rechargeable Cardiosave IABP Lithium-Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this problem.
As of December 18, 2025, Datascope has not received complaints related to this problem. |
| Instructions for Customers/Users |
Customers should note that if you are currently using one of the affected Battery Charging Stations, please follow the instructions in the Battery Charging Instructions section of the customer letter.
A Getinge representative will contact your facility to schedule a service visit. The protruding screw in the Battery Charging Station will be replaced at no cost to your facility.
This action has been closed out on 23/09/2026 |
| Action Commencement Date |
17/02/2026 |
| Responsible Entity |
|
| Contact Information |
1800 438 464. or Quality.AUNZ@getinge.com |