| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01310-1 |
| Product Name/Description |
Aptio Automation Modules. An in vitro diagnostic medical device (IVD).
Module: Refrigerated Storage Module
Material Number:10703049, 10715227, 10703036, 10713762 and 10713767
Module: Centrifuge Module
Material Number: 10703032, 10713761 and 10713764
Module: i2000SR Interface Module
Material Number: 10989303 and 10989304
ARTG Number: 174699 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified with the Aptio Automation Modules. There is a possibility that the plug used to connect the automation system power source may overheat and fail. The plug used to connect to a standard power outlet is not affected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to review customer letter with Medical Director, ensure all users are aware of the issue, return completed Response Form, retain letter with laboratory records and forward letter to those who may have received product. Siemens Customer Service Engineers shall be visiting customer sites to replace the power cords. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |