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Health Canada Medical devices

iMRI 3T S

Issued April 25, 2024
Issue
The recall is being initiated to address a notification received by Deerfield Imaging, Inc. from Siemens regarding potential dot- or line-shaped artifacts caused by the presence of lubricating grease within the headband of the over-ear headphones when used during head examinations with the Magnetom MRI systems. Siemens became aware of this issue during post market surveillance. Siemens has identified that the root cause of the issue was a manufacturing processing error. Recall Start date: April 12, 2024
Hazard description
Performance
Product
Product name
iMRI 3T S
Reference
ID
RA-75443