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Health Canada Medical devices

Siemens Biograph mMR System

Issued March 22, 2024
Issue
Siemens Healthcare GmbH became aware of this issue as part of a customer complaint investigation. It has been identified that this issue can occur when certain parameters (Echo spacings 0.50 MS; 0.51 MS, and 0.52 MS) are used in EPI (Echo-Planar Imaging), sequences will excite high internal stress inside the gradient coil assembly. This may lead to cracks and damage to the gradient coil. Recall start date: March 15, 2024
Hazard description
Performance
Product
Product name
Siemens Biograph mMR System
Reference
ID
RA-75287