| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00909-1 |
| Product Name/Description |
Steelco Washer Disinfectors (Instrument cleaner and disinfectors)
All Steelco washers with an auto load/unload module attached
Catalogue Numbers: STC9935022, STC99911173, STC9991133, STC9995007, STCC210, STCC211, STCC228
ARTG Number: 206635 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
In regular operation, the photo optical sensor at the end of an unloading table would signal that a rack had reached the endpoint of its travel out of a washer chamber and send a command for the unloading arm to return to its home state position. If this sensor is somehow inadvertently obstructed or disturbed during the unloading process of the rack it has the potential to send a message to the Invertor communicating with the PLC that it hadn’t fully unloaded the rack. The system is not able to process the fact that it is unloading a rack at the same time the sensor is telling it that the rack had already been unloaded. In this situation it could cause an unwanted movement of the unloader arm, causing it to come into contact with the washer’s glass door and potentially causing it to break. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In Vitro Technologies will be organising the installation of a software upgrade on all loading and unloading modules. The software change will prevent the system faulting due to unintended obstruction of the unloader sensors.
This action has been closed out on 31/10/2018 |
| Contact Information |
1300 932 136 - In Vitro Technologies |