| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00653-1 |
| Product Name/Description |
Emergency Room Examination Table
Models: 4203.9602
ARTG number: 163023
(Getinge Australia - Table, operation) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Getinge have received reports where the screws holding the reclining surface on the frame have loosened or completely fallen out. The screws that hold the reclining surface on the frame are not secured against unintentional loosening and the tables may experience this issue with daily use over a number of years. If all screws loosen / become detached and this goes unnoticed, the reclining surface of the table may detach resulting in injury to a patient or operator as a result of falling.
To date, no reports of patient injury have been received relating to this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Getinge are advising they will be in contact with impacted users to replace the screws on the table with new screws secured with detent edge discs.
This action has been closed out on 30/11/2021 |
| Contact Information |
1800 438 464 - Getinge Customer Service |