| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00829-1 |
| Product Name/Description |
GETINGE WD15 Claro - Washer Disinfector
Serial Numbers: WAA083548 and WAA082736
ARTG Number: 125655
(Getinge Australia Pty Ltd - Washer, decontamination, utensil) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Getinge have identified a possible water leakage on limited Washer Disinfectors of model type WD15. If this issue occurs, both an acoustic and visual alarm ("A03 OVER FLOW CO" on the machines display) will be present. This leakage may take place during operation in the last part of the cleaning and disinfection cycle. The leaking water has not been processed through the machine and from investigations it does not make contact with critical electrical components of the washer.
If the issue is left unattended, there can be a leakage of cold water out from the water supply to the machine (up to 2 L/min). If users do not respond to the alarm, there may be a significant amount of water on the floor which may result in a person falling and acquiring an injury. There is also a risk for property damage from the water leak.
To date, no injuries have been reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Getinge are advising they are investigating this issue and will provide a solution as soon as it becomes available.
In the interim, users may continue to use the washer, provided that the machine is not left unattended.
Users should react to device alarms immediately.
If an alarm *A03 OVER FLOW CO* is activated, users are advised to do the following;
1. Switch off the main switch;
2. Close shut off valves in the water supply lines; and
3. Contact a service technician.
This action has been closed out on 06/02/2019 |
| Contact Information |
1800 438 464 - Getinge Customer Service |