| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01185-1 |
| Product Name/Description |
STERIS 5085 and 5085SRT Surgical Table
Product codes: ST-01-410-1, ST-01-460-7, ST-480-7 and ST-01-480-06
Serial Number Range: 0403809001-0425514019
ARTG number: 149156 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, STERIS Corporation, has learned through customer feedback and field service experience that the shroud cover for the hydraulic column may become misaligned and damaged as a result of extreme articulation or excessive pressure on the side or base of the table. In most instances, the shroud damage is minor and does not affect the vertical up/down movement of the hydraulic column. In cases of sever shroud damage, the shroud sections may become misaligned such that vertical movement of the hydraulic column is impeded. No patient injury or adverse health outcomes have been reported due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies Australia (DTA) representative will contact the customer to arrange an upgrade to correct the problem. DTA is also advising customers that the 5085/5085SRT Surgical Tables can continue to be operated in the interim. This action has been closed-out on 11/08/2016. |
| Contact Information |
1300 338 423 - Device Technologies Australia |