IMRIS MR/X-ray head fixation device, Model HFD200
Reported: October 30, 2019 Initiated: June 26, 2019 #Z-0163-2020
Product Description
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.
Details
- Recalling Firm
- Deerfield Imaging, Inc.
- Units Affected
- 3 units
- Distribution
- TN, NH, FL
- Location
- Minnetonka, MN
Frequently Asked Questions
What product was recalled? ▼
IMRIS MR/X-ray head fixation device, Model HFD200. Recalled by Deerfield Imaging, Inc.. Units affected: 3 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2019. Severity: Moderate. Recall number: Z-0163-2020.
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