| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00196-1 |
| Product Name/Description |
Getinge Steriliser
Model Number: GSS67H
ARTG Number: 139140
(Getinge Australia - Sterilizer, moist heat, wrapped goods) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Getinge has been made aware that certain GSS67 sterilizers will not work up to specification due to power supply electrical connection issues.
To date, no adverse events have been reported in Australia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Getinge is providing affected users with an upgraded installation manual, service manual and electrical diagrams. For devices shipped prior to 2017 the electrical components of the device will be corrected. Devices shipped after 2017 have already had these components installed.
This action has been closed out on 19/11/2018 |
| Contact Information |
1800 438 464 - Getinge Customer Service |