| TGA Action ID |
RC-2025-RN-00609-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
GETINGE CM320
Product Description: CM320-4 CHAMBER WUWD, CM320-2 CHAMBER WU
Serial Numbers: WAA106391, WAA107872 |
| ARTG Number |
409106 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The devices element connections may overheat due to missing washers or poor tightening of electrical connections and a potential ignition is not smothered by the element cover due to its incorrect material classification.
Getinge have received 2 complaints, where one of the devices had caught fire. There was no injury reported. |
| Instructions for Customers/Users |
Customers should check the serial number of their Getinge CM320 Washer Disinfector to see if it is an affected d product.
A Getinge Sales or Service person will contact customers to schedule the product correction (replacing the element cover), free of charge.
In the meantime, customers can use the machine until the replacement of the cover has been performed if they ensure that the preventive maintenance regarding tightening of the element electrical connections for the device has been conducted according to the service manual and no signs of overheating element connections have been visible.
This action has been closed out on 22/06/2026 |
| Action Commencement Date |
7/07/2025 |
| Responsible Entity |
|
| Contact Information |
Quality.AUNZ@getinge.com |