| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00949-1 |
| Product Name/Description |
Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body MRI System)
ARTG Number: 98485 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
When positioning the coil off centre in the left direction as it is used, for example, a hip and shoulder imaging and, in addition at an off centre position with respect to the head-foot direction, the coil can heat up on the area of the electronic housing (white plastic lids).
To be more precise, heating may occur if each of the following conditions applies at the same time:
- coil positioned off-center in head-foot direction by more than 5cm
- coil at side position
- application of higher RF power over several minutes.
In that position, the surface temperature may well exceed temperatures defined by regulatory standards and may cause local burns to the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing work around instructions for users to follow. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |