Z-0163-2020Class II

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

Name: Z-0163-2020 IMRIS MR/X-ray head fixation device, Model HFD200
Creator: Deerfield Imaging, Inc.
Published: 2019-06-26
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2019-06-26 / Terminated / root cause: design

FDA source

Deerfield Imaging, Inc. began a recall of IMRIS MR/X-ray head fixation device, Model HFD200 on 2019-06-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0163-2020
Classification: Class II
Status: Terminated
Initiated: 2019-06-26
Posted: 2019-10-18
Terminated: 2020-10-29
Recalling firm: IMRIS Imaging, Inc.
Product: IMRIS MR/X-ray head fixation device, Model HFD200
Product code: HBL Holder, Head, Neurosurgical (Skull Clamp)
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 3 units
Distribution: TN, NH, FL
Product codes and lots: HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0163-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0163-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-18

Product code HBL

K113748Class IIImris Mr/x-Ray Head Fixation Device (Hfd)Imris, Inc. / cleared 2012-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)