| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00251-1 |
| Product Name/Description |
Getinge HS33 Sterilsers
Model Numbers: 978053XXX, 978055XXX and 6011978043XXX
Serial Numbers: 11101581, 12031135, 12171741, 12481961, 13122119, 13402211, 13412218, 13412224, 13452238, 14483126
ARTG Number: 275198 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Getinge has identified an issue with Getinge HS33 manual door sterilisers, which can potentially cause the door with manual mechanism to unseal during the process. This can cause potential steam leakage. This potential for malfunction is caused by the design of the door hook which is a part of the door locking mechanism (part number 4839900). When the door has been closed and the sterilisation process has started, the leak may occur through the door gap, however the door will not slide down as the clamping brakes located on both sides of the door hinder the slide down. In case the process must be interrupted due to safety reasons, the emergency stop button will immediately cut off steam supply to the chamber. Getinge's investigation which included risk analysis and evaluation of the worst-case scenario concluded that it is highly unlikely the malfunction would cause or contribute to an injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Getinge has developed a new design of the component (part no 6011000223) to prevent device door to unseal during the process. This action is to replace the existing door hook (part no 4839900) with the new and corrected design.
This action has been closed-out on 21/03/2018. |
| Contact Information |
1300 155 500 - Getinge Group |