| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00208-1 |
| Product Name/Description |
IMRIS ORT100 and ORT300 Operating Room Tables
Part Numbers: 110470-000 and 114093-000
Serial Numbers: 10003241 and 10002255
ARTG Number: 276861
(Emergo Asia Pacific T/a Emergo Australia - Table, x-ray system, diagnostic, general-purpose, powered) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
The ORT100 and ORT300 tables may drift while in use, which could potentially result in unintended movement of the table. The drift occurs slowly over time and typically is not recognised until after several hours.
There have been two reports of injury overseas as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Emergo is advising that the following corrective actions will be undertaken:
· ORT100: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do no pass the drift test, a hydraulic fluid flush and filter change will be performed.
· ORT300: All customer sites with these tables shall have the hydraulic fluid flushed and exchanged for new and the filter element will be changed. A drift test will also be performed.
This action has been closed out on the 26/11/2018. |
| Contact Information |
02 9006 1662 - Emergo Australia |