| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00023-1 |
| Product Name/Description |
Magnetom Spectra 3.0 T System (MRI system)
Catalogue number: 10655588
Serial numbers: 56031, 56029, 56019 & 56017
ARTG number: 154128 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
Due to an isolated production issue, the body coil in the MRI may possibly be fatigued after certain months of usage. This fatigue may potentially lead to the risk of overheating during delivery of RF energy due to underestimated specific absorption rate (SAR) in extremely rare conditions for head, neck and shoulder examinations. Siemens is not currently aware of any incidents related to this issue. However, the risk of overheating which may include tissue damage cannot be totally excluded, although the possibility of occurrence for serious injury is extremely low according to Siemens' risk assessment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised to undertake extra precautions during head, neck and shoulder scans ie, to advise patients to immediately communicate uncomfortable heating sensations so that the scan can be stopped. Body coils will be replaced as soon as possible for the systems which have been identified as having a slight beginning of aging. For the remaining potentially affected systems, tune up measurements and QA checks will be performed by the end of February 2014 to readjust the system if required to eliminate any immediate risk. All potentially affected body coils will be replaced by the end of May 2014. |
| Contact Information |
1800 310 300 - Siemens Technical Support |