Minnetonka, MN, United States
Deerfield Imaging, Inc. recalls
9 recalls recorded since 2018, most recently on 17 February 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)0
Terminated or completed9
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 17 February 2022
- Terminated
- 15 May 2024
- 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 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.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, FL, GA, MA, MN, NC, NY, OH, and TX. The countries of Sweden and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0934-2022
- Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.
Terminated Class II Medical devices
- Recall started
- 25 August 2021
- Terminated
- 30 April 2024
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2585-2021, Z-2584-2021, Z-2586-2021
- Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
- Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
- Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Terminated Class II Medical devices
- Recall started
- 26 November 2019
- Terminated
- 4 August 2020
- 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-ray tube will not be supplied with the required voltage and X-ray will not be possible
- Distribution
- CT, MA, VA. International distribution: Australia, Canada, and Qatar.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0762-2020
- iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (bi
Terminated Class II Medical devices
- Recall started
- 26 June 2019
- Terminated
- 29 October 2020
- 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.
- Distribution
- TN, NH, FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0163-2020
- IMRIS MR/X-ray head fixation device, Model HFD200
Terminated Class II Medical devices
- Recall started
- 6 November 2018
- Terminated
- 25 July 2021
- Reason
- Table may drift in the roll position while in use
- Distribution
- Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0645-2019, Z-0648-2019, Z-0646-2019, Z-0647-2019
- 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 ORT300 are intended for use during diagnostic examinations, radiologic procedure
- IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical
- IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and
- IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, rad
Terminated Class II Medical devices
- Recall started
- 4 April 2018
- Terminated
- 22 July 2020
- 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.
- Distribution
- Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1645-2018
- IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielde
Terminated Class II Medical devices
- Recall started
- 23 February 2018
- Terminated
- 12 September 2019
- Reason
- The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
- Distribution
- US, Canada, China, Australia, Sweden, Germany
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1266-2018, Z-1264-2018, Z-1265-2018, Z-1263-2018
- IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
- IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600
- IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
- IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600
Terminated Class II Medical devices
- Recall started
- 23 February 2018
- Terminated
- 27 August 2019
- Reason
- The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
- Distribution
- US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1217-2018, Z-1218-2018
- IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
- IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Terminated Class II Medical devices
- Recall started
- 20 February 2018
- Terminated
- 27 August 2019
- 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.
- Distribution
- US, Canada, Australia, China, Qatar
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0976-2018, Z-0975-2018
- IMRIS T2X Table, Part Number 109682-600
- IMRIS ORT100 Table, Part Number 110470-000
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.