Deerfield Imaging, Inc.

United StatesFDA applicant, unverified

Devices: 2
FDA recalls: 21

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Deerfield Imaging, Inc. makes

Deerfield Imaging, Inc. manufactures intraoperative magnetic resonance imaging (MRI) systems, including the InVision™ 1.5 Surgical Theatre and the IMRIS iMRI 3T V. These devices enable real-time MRI imaging during surgical procedures, supporting precision guidance and monitoring of interventions.

The company’s portfolio is classified under FDA Class II devices and is subject to 510(k) clearance in the United States. The systems are designed for use in surgical environments where MRI compatibility is required for patient safety and procedural accuracy.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

InVision™ 1.5 Surgical Theatre Ref K240157

Active Regimes: 510(k) Registry: 510(k) Class:II
IMRIS iMRI 3T V Ref K212367 Open recall

Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls21

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 21 recalls initiated by Deerfield Imaging, Inc., the earliest on 2016-02-10 and the most recent on 2022-02-17. By recorded status: 21 terminated. The reasons filed fall into these groups: electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 1
2018 13
2019 2
2020 0
2021 3
2022 1
2023 0
2024 0
2025 0
2026 0

1 initiated before 2017

Showing the 10 most recent of 21 recalls.

2022
- 17 Feb 2022 Z-0934-2022 Class II Terminated 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…
  Full distribution text
  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.
  Submission number: K103493
2021
- 25 Aug 2021 Z-2584-2021 Class II Terminated 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,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
- 25 Aug 2021 Z-2585-2021 Class II Terminated 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,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
- 25 Aug 2021 Z-2586-2021 Class II Terminated 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,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
2019
- 26 Nov 2019 Z-0762-2020 Class II Terminated 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. Submission number: K101813
- 26 Jun 2019 Z-0163-2020 Class II Terminated 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 Submission number: K113748
2018
- 6 Nov 2018 Z-0645-2019 Class II Terminated 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,…
  Full distribution text
  Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.
- 6 Nov 2018 Z-0646-2019 Class II Terminated 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,…
  Full distribution text
  Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.
- 6 Nov 2018 Z-0647-2019 Class II Terminated 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,…
  Full distribution text
  Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.
- 6 Nov 2018 Z-0648-2019 Class II Terminated 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,…
  Full distribution text
  Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.

Show all 21 recalls

2018
- 4 Apr 2018 Z-1645-2018 Class II Terminated 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 Submission number: K133692
- 23 Feb 2018 Z-1217-2018 Class II Terminated 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
- 23 Feb 2018 Z-1218-2018 Class II Terminated 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
- 23 Feb 2018 Z-1263-2018 Class II Terminated 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
- 23 Feb 2018 Z-1264-2018 Class II Terminated 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
- 23 Feb 2018 Z-1265-2018 Class II Terminated 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
- 23 Feb 2018 Z-1266-2018 Class II Terminated 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
- 20 Feb 2018 Z-0975-2018 Class II Terminated 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
- 20 Feb 2018 Z-0976-2018 Class II Terminated 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
2017
- 14 Aug 2017 Z-3211-2017 Class II Terminated incorrect thread on thumbscrews Distribution: IL, OR, PA Submission number: K103493
2016
- 10 Feb 2016 Z-1098-2016 Class II Terminated Emergency helium venting lines (i.e. quench lines) may not have been properly installed. Distribution: Worldwide Distribution -- US, including the states of CA, CT, FL, GA, IL, IN, MD, MA, MN, MO, NH, NC, OH, OR, PA, TX,…
  Full distribution text
  Worldwide Distribution -- US, including the states of CA, CT, FL, GA, IL, IN, MD, MA, MN, MO, NH, NC, OH, OR, PA, TX, UT, VA, and WI; and ,countries of CHINA, CANADA, AUSTRALIA, FRANCE, JAPAN, and GERMANY.
  Submission numbers: K061916, K071099, K083137, K133692

Frequently asked questions

How many devices does Deerfield Imaging, Inc. have in the registry?

The registry currently lists 2 devices for Deerfield Imaging, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Deerfield Imaging, Inc.'s devices?

Among its 2 most recently registered devices, Deerfield Imaging, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Deerfield Imaging, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Deerfield Imaging, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Deerfield Imaging, Inc.?

FDA recall records list 21 recalls initiated by Deerfield Imaging, Inc., the most recent initiated on 2022-02-17. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Deerfield Imaging, Inc. in the registry?

The most recently registered devices listed for Deerfield Imaging, Inc. include InVision™ 1.5 Surgical Theatre and IMRIS iMRI 3T V.

Generated automatically from registry data and not verified by a human reviewer.