| TGA Action ID |
RC-2026-RN-00739-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
KayserBetten Safe Surround Genie Bed
Product code: 7959-0016-000
Date of Manufacture: Before or on 9 July 2025
Multiple serial numbers |
| ARTG Number |
151342 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class I |
| Reason for the Action |
The KayserBetten Safe Surround Genie Bed hand control does not automatically lock after use. If it is not locked with the key when the user is unattended, the user or another person may operate the bed. Someone could mistakenly use the hand control and accidentally move the bed.
This could cause trapping beneath or between moving parts, resulting in serious injury or death. Two (2) deaths have been reported in relation to this problem. |
| Instructions for Customers/Users |
Customers are to:
Strictly observe the following interim safety measures, until the new Auto-Lock hand control is fitted.
Whenever the user is unattended:
· Move the sleeping platform to a level position and its lowest height.
· Lock all hand control functions using the key
· Close the bed doors
Medifab will contact customers to organise an appointment. At this appointment a Medifab staff member will remove the original hand control, install the new Auto-Lock hand control, perform a functional check, and explain its operation to the user or caregiver. |
| Action Commencement Date |
1/10/2026 |
| Responsible Entity |
|
| Contact Information |
1300 543 343 - Medifab Australia |