| TGA Action ID |
RC-2026-RN-00255-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Steam Sterilizers with vertical moving doors
Multiple Model Numbers
All Serial Numbers
Distributed prior to 04 September 2019
ARTGs 139140 (Cancelled) & 190906 (Cancelled) |
| ARTG Number |
|
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Getinge Sterilization AB received a report of a user injury involving the autoclave door. The sterilisation technician activated the door lock while a basket was obstructing the door’s movement. Rather than reopening the door and repositioning the basket, the technician attempted to manually adjust the basket while the door was closing. When the basket became dislodged, the door closed and resulted in a serious crushing injury to the technician’s hand. During further investigation, a second complaint involving a similar device was also identified. |
| Instructions for Customers/Users |
Customers are to:
1. Continue operating the affected sterilisers in accordance with the Instructions for Use and all safety precautions described in the User Manual.
2. Ensure that all relevant personnel are informed of and adhere to the following safety measures:
o The emergency stop button must be used prior to attempting to reposition any load or obstruction that may interfere with door movement.
o Personnel must not reach into the chamber when the door is stuck, obstructed, or in motion.
3. Complete the Customer Response Form and return it to Quality.AUNZ@getinge.com. |
| Action Commencement Date |
12/08/2026 |
| Responsible Entity |
|
| Contact Information |
Quality.AUNZ@getinge.com - Getinge |