Deerfield Imaging recalls a table adapter component for IMRIS HFD100 head fixation devices. The split block clamp may deflect after force application, risking unnoticed movement during surgery and extended anesthesia time.
Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.
Deerfield Imaging recalls a specific component for their IMRIS HFD100 head fixation system. The component can move unexpectedly during use, potentially causing unnoticed surgical shifts or longer anesthesia times for patients.
The split block clamp can rotate after routine lateral forces are applied and may not return to its original position. This could cause the surgical table to move unnoticed during procedures, requiring additional steps like reestablishing navigation or extending anesthesia time for the patient.
Surgical teams using the IMRIS HFD100 head fixation system with the recalled component are most at risk. Patients undergoing procedures with this specific component may experience extended anesthesia time or require reestablished navigation.
Check for the part number 118704-000 on the IMRIS HFD100 head fixation device. The affected models have specific serial numbers listed in the recall notice.
Inspect the split block clamp for signs of deflection after applying lateral force. If it does not return to its original position, it may be affected.
The recall states that the component can deflect after normal use, so it may pose a risk even with proper application.
Check for the part number 118704-000 on the IMRIS HFD100 head fixation device. Affected models have specific serial numbers listed in the recall notice.
The recall does not specify a stop-use action; users are advised to check for deflection and consider the risk before proceeding.
We’ve drafted a message you can send Deerfield Imaging to request your refund or repair — edit it as you like.
Subject: Recall Z-0934-2022 — Deerfield Imaging Deerfield Imaging Hello, I own a Deerfield Imaging that is covered by recall Z-0934-2022 from Deerfield Imaging. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
