| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00248-1 |
| Product Name/Description |
Steelco DS1000 Washer Disinfectors with an auto load/unload module attached
(Instrument cleaner and disinfectors)
Model Number: DS1000 1S
Catalogue Numbers: STCDS10001S_STEAM, STCDS10001S_MIXED, STCDS10001SR_STEAM
Model Number: DS1000 2S
Catalogue Number: STCDS10002S_MIXED
Model Number: DS1000 3S
Catalogue Numbers: STCDS10003S, STC9930030; STCDS10003S_MIXED, STCDS10003S_STEAM
ARTG Number: 206635 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
This action is further to the one in July 2016 (TGA Ref.: RC-2016-RN-00909-1) that was for all Steelco washers with auto load/unload module. This issue relates to DS1000 washers, which need another s/w update. 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 & send a command for the unloading arm to return to its home state position. If this sensor is somehow inadvertently obstructed/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. This situation could cause an unwanted movement of the unloader arm, causing it to come into contact with the washer’s glass door & 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 the PLC of all DS1000 washers installed with unloaders. This software change will eliminate the incorrect closure of the machine door due to unintended obstruction of the optical sensors or external parts placed on the table.
This action has been closed out on 11/10/2018 |
| Contact Information |
1300 932 156 - In Vitro Technologies |