| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00515-1 |
| Product Name/Description |
MAGNETOM Aera (Full Body MRI System)
Catalogue Number: 10432914
ARTG Number: 98485 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that an incomplete set of Operator Manuals has been supplied for the following coils and options for the MAGNETOM Aera system:
· 4 Ch BI Breast
· 16 Ch AI Breast
· Breast 18
· 2-4-8 Ch Breast Coil Sentinelle
· MR-Elastography option
The instructions and the safety information that is missing from the manuals cannot be consulted when needed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Updated Operator Manuals will be supplied to customers with the customer letter or will be sent soon by courier. Users are advised to study the missing manuals provided, especially the safety information included in the manuals. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |