| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00113-1 |
| Product Name/Description |
Biograph mMR with software version syngo E11P
Catalogue Number:10433372
ARTG Number: 274035 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has been notified by the manufacturer that a mismatch has been identified between orientation labels and displayed anatomy (e.g. in the 3D task card) within the software Version syngo E11P. This will lead to wrong attenuation correction of the PET data.
The issue occurs when changing the image numbering in transversal MRAC protocol (e.g. MRAC_CAIPI_HiRes protocol) from the default setting "Feet>>Head" to a customised setting "Head>>Feet". The original images are labelled correctly, but the composed images are flipped by 180 degrees and shifted.
There have been no injuries reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens is advising that this issue will be corrected in the next service pack syngoE11P-SP03. In the interim, do not change the numbering of images in transversal MRAC protocols (within an MRPET workflow). Follow the user manual. Don't rely only on composed images; always additionally refer to the original images for diagnostic purposes.
This action has been closed out on 06/02/2019 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |