| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01114-1 |
| Product Name/Description |
Dimension Integrated Chemistry Systems.
Dimension EXL with LM
Dimension Reagent Management System (RMS)
Dimension RxL Max HM
Catalogue Numbers: 10472176, 10444833 and 10444829
ARTG Number: 174699
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container. The absence of the safety cover results in a potential electrical hazard to the operator. This issue does not impact patient results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing a safety warning to be placed on the machine as an interim measure. A service engineer will be inspecting all units and installing a cover where required.
This action has been closed out on 25/10/2018 |
| Contact Information |
1800 310 300 - Technical Support Centre |