CLASS II Device recall · Reported 30 Oct 2019 · FDA Enforcement Report

Imris MR/X-ray head fixation device recalled by Deerfield Imaging

Deerfield Imaging is recalling Imris MR/X-ray head fixation device, distributed in Florida, New Hampshire, Tennessee. The recall was initiated on 26 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesHFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448

Quantity recalled3 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0163-2020
FDA event ID: 83278
Recalling firm: Deerfield Imaging, Minnetonka, MN
Classification: Class II
Status: Terminated
Recall initiated: 26 Jun 2019
FDA classified: 18 Oct 2019
Reported: 30 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

26 Jun 2019	Recall initiated by company
18 Oct 2019	Classified by FDA	+114 days
30 Oct 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

TN, NH, FL

Florida New Hampshire Tennessee

Questions about this recall

Is Imris MR/X-ray head fixation device recalled?

Yes. Deerfield Imaging recalled Imris MR/X-ray head fixation device on 26 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-0163-2020.

Why was it recalled?

Which lots are affected?

HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448

Where was it sold?

TN, NH, FL

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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