FDAFDA · Food and drugs·Recall number Z-0163-2020
IMRIS MR/X-ray head fixation device, Model HFD200
Published October 30, 2019 · Recall initiated: June 26, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Deerfield Imaging, Inc.
- Distributor
- TN, NH, FL
- Lot
- HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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