Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Trumpf Mount Clamp Assembly (table adapter component) Recalled by Deerfield Imaging, Inc. Due to Reports have been received that after normal or...

Date: February 17, 2022
Company: Deerfield Imaging, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Deerfield Imaging, Inc. directly.

Affected Products

Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.

Quantity: 24

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Deerfield Imaging, Inc.

Deerfield Imaging, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report