IMRIS Imaging Inc. is recalling 122 units of the Head Fixation Device HFD100 due to reports that a torque screw may crack or separate. This device is used to stabilize a patient's head during neurosurgery and imaging to ensure surgical precision. If the screw fails, it can lead to inadequate head stabilization, loss of surgical accuracy, and procedural delays. Clinical staff should stop using affected devices and contact the manufacturer to arrange for a replacement or correction.
A cracked or separated torque screw can cause the head stabilization system to fail during delicate neurosurgical procedures. This poses a significant risk of patient injury, loss of surgical precision, and required use of alternative fixation methods mid-procedure.
The HFD100 Head Fixation Device provides rigid skeletal fixation during imaging and surgery. The system includes linkage components and a 3-pin skull clamp.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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