Home / Recalls / Deerfield Imaging, Inc. / Z-0163-2020

Z-0163-2020 Class II Terminated

Recalled by Deerfield Imaging, Inc. — Minnetonka, MN

Recall Details

Product Type
Devices
Report Date
October 30, 2019
Initiation Date
June 26, 2019
Termination Date
October 29, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

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

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.

Distribution Pattern

TN, NH, FL

Code Information

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

Other recalls by Deerfield Imaging, Inc.

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  • Z-2584-2021 Class II — Operating room table - Product Usage: intended for use during diagnostic examina (August 25, 2021)
  • Z-2585-2021 Class II — Operating room table - Product Usage: intended for use during diagnostic examina (August 25, 2021)
  • Z-2586-2021 Class II — Operating room table - Product Usage: intended for use during diagnostic examina (August 25, 2021)
  • Z-0762-2020 Class II — iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/i (November 26, 2019)
  • Z-0645-2019 Class II — IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) (November 6, 2018)
  • Z-0648-2019 Class II — IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b (November 6, 2018)
  • Z-0647-2019 Class II — IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b (November 6, 2018)
  • Z-0646-2019 Class II — IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usa (November 6, 2018)
  • Z-1645-2018 Class II — IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI (April 4, 2018)