IMRIS HFD100 Head Fixation Device
Brand(s)
Last updated
Summary
Product
IMRIS HFD100 Head Fixation Device
Issue
Medical devices - Performance
What to do
Manufacturer to contact users to arrange time to replace affected torque screw component with improved device.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| HFD100 Head Fixation Device | 10003936 | 111361-000 |
| HFD100 Head Fixation Device | 10003937 | 111361-000 |
| HFD100 Head Fixation Device | 10005092 | 113802-000 |
| HFD100 Head Fixation Device | 10011463 | 113803-000 |
| HFD100 Head Fixation Device | 10007237 | 113803-000 |
| HFD100 Head Fixation Device | 10007509 | 113803-000 |
| HFD100 Head Fixation Device | 10005134 | 113803-000 |
| HFD100 Head Fixation Device | 10005711 | 113803-000 |
Issue
IMRIS is conducting a voluntary recall to address a potential safety risk associated with use of the HFD100 Head Fixation Device and will be completing corrective action to remove and replace the torque screw component in all HFD100 Head Fixation Devices at all affected customer sites.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Imris Imaging, Inc.
1230 Chaska Creek Way, Chaska, Minnesota, United States, 55318
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81373
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