No image published for this recall

No image published for this recall

Imris hfd100 head fixation device

Official notice

17 Dec 2025

Last checked

17 Dec 2025

Medium riskHealth Canada

An official Health Canada notice concerns Imris hfd100 head fixation device. 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. Published 2025-12-17.

What to do now

Manufacturer to contact users to arrange time to replace affected torque screw component with improved device.

Recall number

81373

Official notice

2025-12-17

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

10003936, 10003937, 10005092, 10011463, 10007237, 10007509, 10005134, 10005711

Skus

111361-000, 113802-000, 113803-000

Other

RA RA-81373

Model Numbers

111361-000, 113802-000, 113803-000

Recall Numbers

81373

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Affected products

Product 1

Affected products - HFD100 Head Fixation Device, Lot or serial number - 10003936, Model or catalogue number - 111361-000

Product 2

Affected products - HFD100 Head Fixation Device, Lot or serial number - 10003937, Model or catalogue number - 111361-000

Product 3

Affected products - HFD100 Head Fixation Device, Lot or serial number - 10005092, Model or catalogue number - 113802-000

Product 4

Affected products - HFD100 Head Fixation Device, Lot or serial number - 10011463, Model or catalogue number - 113803-000

Product 5

Affected products - HFD100 Head Fixation Device, Lot or serial number - 10007237, Model or catalogue number - 113803-000

Product 6

Affected products - HFD100 Head Fixation Device, Lot or serial number - 10007509, Model or catalogue number - 113803-000

Product 7

Affected products - HFD100 Head Fixation Device, Lot or serial number - 10005134, Model or catalogue number - 113803-000

Product 8

Affected products - HFD100 Head Fixation Device, Lot or serial number - 10005711, Model or catalogue number - 113803-000

Product 9

Lot or serial number - 10003936, Model or catalogue number - 111361-000

Product 10

Lot or serial number - 10003937, Model or catalogue number - 111361-000

Product 11

Lot or serial number - 10005092, Model or catalogue number - 113802-000

Product 12

Lot or serial number - 10011463, Model or catalogue number - 113803-000

Product 13

Lot or serial number - 10007237, Model or catalogue number - 113803-000

Product 14

Lot or serial number - 10007509, Model or catalogue number - 113803-000

Product 15

Lot or serial number - 10005134, Model or catalogue number - 113803-000

Product 16

Lot or serial number - 10005711, Model or catalogue number - 113803-000

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Imris Imaging.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81373

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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