Deerfield Imaging, Inc. IMRIS MR/X-ray head fixation device, Model HFD200 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMRIS MR/X-ray head fixation device, Model HFD200
Brand
Deerfield Imaging, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448
Deerfield Imaging, Inc. is recalling IMRIS MR/X-ray head fixation device, Model HFD200 due to Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm disseminated a field safety notice on 06/26/2019 by letter. The notice explained the problem and requested that the consignee inspect the skull clamp prior to use and be aware that overtightening of the drive knob may result in failure. The drive knobs will be replaced with an updated design when available.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, NH, TN
Page updated: Jan 10, 2026