FDA-Device2019-10-30Class II
IMRIS MR/X-ray head fixation device, Model HFD200
Deerfield Imaging, Inc.
Hazard
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.
Sold states
TN, NH, FL
Affected count
3 units
Manufactured in
5101 Shady Oak Rd S, Minnetonka, MN, United States
Products
IMRIS MR/X-ray head fixation device, Model HFD200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0163-2020Don't want to check this manually?
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