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Deerfield Imaging Recalls
21 recalls on record · March 23, 2016 to April 20, 2022 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 20, 2022Medical DevicesFDA
Deerfield Imaging, Inc. recalls Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation d
Hazard: 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 distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.
October 6, 2021Medical DevicesFDA
Deerfield Imaging, Inc. recalls Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical
Hazard: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
October 6, 2021Medical DevicesFDA
Deerfield Imaging, Inc. recalls Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical
Hazard: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
October 6, 2021Medical DevicesFDA
Deerfield Imaging, Inc. recalls Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical
Hazard: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
January 8, 2020Medical DevicesFDA
Deerfield Imaging, Inc. recalls iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI
Hazard: 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-ray tube will not be supplied with the required voltage and X-ray will not be possible
October 30, 2019Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS MR/X-ray head fixation device, Model HFD200
Hazard: 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.
December 26, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200
Hazard: Table may drift in the roll position while in use
December 26, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148
Hazard: Table may drift in the roll position while in use
December 26, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended f
Hazard: Table may drift in the roll position while in use
December 26, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Us
Hazard: Table may drift in the roll position while in use
May 16, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that
Hazard: 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.
April 4, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
Hazard: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
April 4, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
Hazard: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
April 4, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-
Hazard: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
April 4, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600
Hazard: The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
April 4, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surg
Hazard: The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
April 4, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surg
Hazard: The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
March 21, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS T2X Table, Part Number 109682-600
Hazard: 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.
March 21, 2018Medical DevicesFDA
Deerfield Imaging, Inc. recalls IMRIS ORT100 Table, Part Number 110470-000
Hazard: 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.
October 4, 2017Medical DevicesFDA
Deerfield Imaging recalls IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
Hazard: incorrect thread on thumbscrews
March 23, 2016Medical DevicesFDA
Deerfield Imaging recalls Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic
Hazard: Emergency helium venting lines (i.e. quench lines) may not have been properly installed.