medical Class II Updated 2019-10-30

Deerfield Imaging, Inc. recalls IMRIS MR/X-ray head fixation device, Model HFD200

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: TN, NH, FL
Lot/Code Info: HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448
View official government recall

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