Reported Oct 30, 2019 · Terminated
IMRIS MR/X-ray head fixation device, Model HFD200
Deerfield Imaging, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Deerfield Imaging, Inc. · 5101 Shady Oak Rd S · Minnetonka, MN · 55343-4100
Is this the product you have?
- IMRIS MR/X-ray head fixation device, Model HFD200
- Lot codes and dates
- HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448
- Amount recalled
- 3 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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