| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00884-1 |
| Product Name/Description |
STERIS 4085, 4085 SS and 4085 Feather Weight Leg Section (FLWS) Surgical tables
Product Codes: ST-01-360-1, ST-01-380-1 and ST-01-360-7
All batches manufactured between 3 July 2009 and 20 June 2014
Multiple affected serial numbers
ARTG number: 149156 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
STERIS has determined there is a potential that if the surgical table feet become unlocked from the floor during a procedure, the hand control may incorrectly indicate that the table feet are locked and still contacting the floor. The user may not realise that the table is unlocked and is able to continue articulating the table using the hand control. No patient injury or adverse health outcomes have been reported due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Should this occur, users are advised that the table can be relocked by pressing the Floor Lock button on the table hand control. As soon as parts are available a Device Technologies representative will contact customers to schedule the installation of new hardware and updated software on all affected Surgical tables. In addition, a new copy of the 4085 Surgical Table Operator Manual will be provided during this site visit. Users may continue to operate all 4085 series surgical tables prior to the completion of the update. This action has been closed-out on 19/08/2016. |
| Contact Information |
1300 338 423 - Device Technologies Austrlaia |