CanadaImris Imaging’s HFD100 Head Fixation Device (models 111361-000, 113802-000, 113803-000; serial/lot numbers 10003936, 10003937, 10005092, 10011463, 10007237, 10007509, 10005134, 10005711) is affected. The devices are being recalled to address a potential safety risk by removing and replacing the torque screw component, and the manufacturer will contact users to arrange replacement.
What's being recalled
Companies: Imris Imaging, Inc., 1230 Chaska Creek Way, Chaska, Minnesota, United States, 55318.
How to identify it
Affected products: HFD100 Head Fixation Device; Lot or serial number: 10003936; Model or catalogue number: 111361-000
Affected products: HFD100 Head Fixation Device; Lot or serial number: 10003937; Model or catalogue number: 111361-000
Affected products: HFD100 Head Fixation Device; Lot or serial number: 10005092; Model or catalogue number: 113802-000
Affected products: HFD100 Head Fixation Device; Lot or serial number: 10011463; Model or catalogue number: 113803-000
Affected products: HFD100 Head Fixation Device; Lot or serial number: 10007237; Model or catalogue number: 113803-000
Affected products: HFD100 Head Fixation Device; Lot or serial number: 10007509; Model or catalogue number: 113803-000
Affected products: HFD100 Head Fixation Device; Lot or serial number: 10005134; Model or catalogue number: 113803-000
Affected products: HFD100 Head Fixation Device; Lot or serial number: 10005711; Model or catalogue number: 113803-000
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.
What to do
Manufacturer to contact users to arrange time to replace affected torque screw component with improved device.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)