Deerfield Imaging recalls

Deerfield Imaging appears in 21 official U.S. recall notices indexed by RecallRadar, most recently on 2022-04-20.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #1196…
  FDA Device · Class II · 2022-04-20 · Deerfield Imaging
  Reason: Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distan…
• Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
  FDA Device · Class II · 2021-10-06 · Deerfield Imaging
  Reason: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
• Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
  FDA Device · Class II · 2021-10-06 · Deerfield Imaging
  Reason: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
• Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to supp…
  FDA Device · Class II · 2021-10-06 · Deerfield Imaging
  Reason: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
• iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiograp…
  FDA Device · Class II · 2020-01-08 · Deerfield Imaging
  Reason: There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-r…
• IMRIS MR/X-ray head fixation device, Model HFD200
  FDA Device · Class II · 2019-10-30 · Deerfield Imaging
  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…
• IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are inte…
  FDA Device · Class II · 2018-12-26 · Deerfield Imaging
  Reason: Table may drift in the roll position while in use
• IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagno…
  FDA Device · Class II · 2018-12-26 · Deerfield Imaging
  Reason: Table may drift in the roll position while in use
• IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage…
  FDA Device · Class II · 2018-12-26 · Deerfield Imaging
  Reason: Table may drift in the roll position while in use
• IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and…
  FDA Device · Class II · 2018-12-26 · Deerfield Imaging
  Reason: Table may drift in the roll position while in use
• IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on…
  FDA Device · Class II · 2018-05-16 · Deerfield Imaging
  Reason: The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.
• IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
  FDA Device · Class II · 2018-04-04 · Deerfield Imaging
  Reason: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
• IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to…
  FDA Device · Class II · 2018-04-04 · Deerfield Imaging
  Reason: The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
• IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600
  FDA Device · Class II · 2018-04-04 · Deerfield Imaging
  Reason: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
• IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
  FDA Device · Class II · 2018-04-04 · Deerfield Imaging
  Reason: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
• IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600
  FDA Device · Class II · 2018-04-04 · Deerfield Imaging
  Reason: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
• IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to…
  FDA Device · Class II · 2018-04-04 · Deerfield Imaging
  Reason: The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
• IMRIS ORT100 Table, Part Number 110470-000
  FDA Device · Class II · 2018-03-21 · Deerfield Imaging
  Reason: The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.
• IMRIS T2X Table, Part Number 109682-600
  FDA Device · Class II · 2018-03-21 · Deerfield Imaging
  Reason: The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.
• IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
  FDA Device · Class II · 2017-10-04 · Deerfield Imaging
  Reason: incorrect thread on thumbscrews
• Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic d…
  FDA Device · Class II · 2016-03-23 · Deerfield Imaging
  Reason: Emergency helium venting lines (i.e. quench lines) may not have been properly installed.