FDA Medical Device Recalls (openFDA)
Deerfield Imaging, Inc.: IMRIS MR/X-ray head fixation device, Model HFD200
- Recall number
- Z-0163-2020
- Recalling firm
- Deerfield Imaging, Inc.
- Product
- IMRIS MR/X-ray head fixation device, Model HFD200
- Status
- Terminated
- Initiated
- 2019-06-26
- Posted
- not on file
- Terminated
- 2020-10-29
- Reason
- 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
- 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
- 3 units
- Distribution
- TN, NH, FL
- Lot, serial or model codes
- HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448
- 510(k) numbers
- ["K113748"]
- PMA numbers
- not on file
- Product code
- HBL
- Firm FEI
- 3010326005
- Firm city
- Minnetonka
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28