# FDA recall Z-0163-2020

> **Deerfield Imaging, Inc.** · Class II · device recall initiated 2019-06-26.

## Product

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

## 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.

## Distribution

TN, NH, FL

## Key facts

- **Recall number:** Z-0163-2020
- **Recalling firm:** Deerfield Imaging, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-26
- **Report date:** 2019-10-30
- **Termination date:** 2020-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minnetonka, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0163-2020

## Citation

> AI Analytics. FDA recall Z-0163-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0163-2020. Source: US FDA. Licensed CC0.

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