Deerfield Imaging recalls HFD200 MR/X-ray head fixation devices due to potential improper skull pinning from drive knob force indicator failure. Affected units have specific serial numbers.
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.
Deerfield Imaging is recalling its HFD200 head fixation device because the drive knob force indicator can break under over-torqueing, leading to either insufficient or excessive force on the patient's skull. This could cause injury during medical procedures if not properly monitored.
The drive knob force indicator can break if the device is torqued beyond its maximum allowable force. This may cause clinical staff to unknowingly apply too little or too much pressure on the patient's skull during procedures, potentially causing injury.
Clinical staff using the HFD200 device for MRI or X-ray procedures are most at risk, particularly when the drive knob force indicator fails due to over-torqueing.
Check for the HFD200 model with specific serial numbers: 10002481, 10003305, 10002351, 10005723, 10004247, 10002448. These units were sold with the drive knob force indicator that can fail.
Verify if your HFD200 device has one of the listed serial numbers: 10002481, 10003305, 10002351, 10005723, 10004247, 10002448.
The drive knob force indicator can break under over-torqueing, potentially causing clinical staff to apply insufficient or excessive force on the patient's skull during procedures.
Check if your HFD200 has one of the listed serial numbers. If it does, you may need to use caution as the device could fail during procedures.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Deerfield Imaging to request your refund or repair — edit it as you like.
Subject: Recall Z-0163-2020 — Deerfield Imaging Deerfield Imaging Hello, I own a Deerfield Imaging that is covered by recall Z-0163-2020 from Deerfield Imaging. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
