IMRIS Imaging recalled 122 Head Fixation Devices on December 8, 2025. A torque screw may crack or separate, posing serious risks during surgical procedures. Healthcare providers must stop using the device and follow recall instructions immediately.
Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact IMRIS Imaging Inc or your healthcare provider for instructions. Notification method: Letter
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Affected models include HFD100 with catalog numbers 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, and 113802-600. The device was distributed worldwide, including the US, Canada, and Japan.
The torque screw in the device may crack or separate, which can lead to inadequate head stabilization during surgeries. This defect can compromise surgical precision and result in procedural delays.
There have been no reported injuries or deaths associated with this recall. However, the risk of patient injury remains significant due to compromised device functionality.
Stop using the Head Fixation Device immediately. Contact IMRIS Imaging Inc or your healthcare provider for further instructions on the recall process.
For more information, contact IMRIS Imaging at 1-800-XXX-XXXX or visit their website. Additional details can also be found in the recall notice.
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