| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00105-1 |
| Product Name/Description |
Enterprise 8000 Electrical Bed
Model Numbers: 5000, 8000, 9000, E5000X, E8000X, E9000X
ARTG Number: 283224
(Arjo Australia - Bed, general-purpose, electrical) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
21/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has become aware of the potential for loose brake pedal screws (part number S1306) which are responsible for connecting the brake pedal with the base frame of the bed and keeping the brake in the correct position. This issue of loose screws is visible to users. There is no evidence to suggest that this anomaly is related with any potential risk to users. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Arjo is advising users to inspect the beds to determine if the screws are loose on the brake mechanism.
If users see that the screw is not tightened fully, it means thatthe device is affected by this correction.
Check the castor operation, paying attention to steering and/or braking function. If users detect small movements between the parts and loose movement between braking system, it means the device may be affected by this correction.
Arjo will be inspecting the affected devices and replacing the affected screws during the next service visit.
Users that undertake serving of their own devices are advised to unscrew the old screw S1306 and replace with new one, by use the torque wrench with 10.2 Nm torque.
This action has been closed out on 11/11/2019 |
| Contact Information |
1800 072 040 - Customer Service Support |