iMRI 3T S
Brand(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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