Health product recall

iMRI 3T S

Last updated

Summary

Product
iMRI 3T S
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

iMRI 3T S

10093-01

116118-000

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Deerfield Imaging, Inc.

1230 Chaska Creek Way, Chaska, Minnesota, United States, 55318

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75443

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