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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The HFD100 Head Fixation Device is used in surgical settings to stabilize a patient's head during imaging or surgical procedures. It is crucial for ensuring precision and safety during operations.
The device's torque screw can crack or separate, compromising the fixation of the patient's head, which may lead to serious surgical risks.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers who rely on this device for surgeries, posing potential delays and the need for alternative stabilization methods.
The model and serial numbers can typically be found on the device label or in the user manual.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep records of all correspondence with the manufacturer, including emails and letters regarding the recall.
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.
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