Recall Z-0934-2022— Deerfield Imaging, Inc.

Name: FDA recall Z-0934-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-17

Class II · Terminated

Class II FDA medical device recall by Deerfield Imaging, Inc., initiated 2022-02-17, terminated 2024-05-15. It names one FDA 510(k) clearance: K103493. Product: 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.. Reason: 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..

Recalling firm: Deerfield Imaging, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-02-17
Terminated: 2024-05-15
Firm location: Minnetonka, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K103493 — HEAD FIATION DEVICE (HFD 100)Imris, Inc.·cleared 2011-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.