Deerfield Imaging, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0163-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

IMRIS MR/X-ray head fixation device, Model HFD200

Product Classification:

Class II

Date Initiated: June 26, 2019

Date Posted: October 30, 2019

Recall Number: Z-0163-2020

Event ID: 83278

Reason for Recall:

Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning the patient's skull with insufficient force; the clinical staff unknowingly pinning the patient's skull with excessive force; or the clinical staff identifying the issue and not being able to continue with the procedure.

Status: Terminated

Product Quantity: 3 units

Code Information:

HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448

Distribution Pattern:

TN, NH, FL

Voluntary or Mandated:

Voluntary: Firm initiated