Health product recall

IMRIS HFD100 Head Fixation Device

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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