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Use caution Medical device recall · FDA · Published April 4, 2018

Deerfield Imaging IMRIS MRI Systems Recall: Magnetic Field Causes Control Panel

Deerfield Imaging recalls IMRIS 1.5T and 3T intraoperative MRI systems due to magnetic field causing IFOSS control panel malfunction. Affected units have specific serial numbers.

🇺🇸 FDA recall #Z-1645-2018Medical deviceDeerfield Imaging ›
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Recalling firmDeerfield Imaging, Inc.5101 Shady Oak Rd S · Minnetonka, MN 55343-4100
✎ GovInfoNow plain-language explainer

Deerfield Imaging is recalling IMRIS 1.5T and 3T intraoperative MRI systems because the magnetic field can cause the IFOSS control panel to malfunction. This could lead to improper operation during surgery if not addressed. Read more at govinfonow.com/recall/71546-deerfield-imaging-imris-mri-systems-recall-magnetic-field-causes-control.

Source Summary by GovInfoNow · govinfonow.com/recall/71546-deerfield-imaging-imris-mri-systems-recall-magnetic-field-causes-control · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1645-2018

Cite this page

“Deerfield Imaging IMRIS MRI Systems Recall: Magnetic Field Causes Control Panel.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71546-deerfield-imaging-imris-mri-systems-recall-magnetic-field-causes-control. Based on FDA recall #Z-1645-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1645-2018%22&limit=1).

The FDA announced on April 4, 2018, that Deerfield Imaging, Inc. voluntarily recalled IMRIS IMRI 1.5T AND 3T S System intraoperative MRI devices due to a malfunctioning collision detector control panel. The agency issued recall number Z-1645-2018 for the Class II device.

How to tell if you have it

  • Brand: Deerfield Imaging
  • Product: IMRIS IMRI 1.5T AND 3T S System
  • Serial Numbers: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01
  • Quantity: 10 units

The hazard

According to the FDA, the magnetic field adversely affects the DC power to the IFOSS collision detector control panel. This causes the control panel to malfunction.

Context

GovInfoNow's records show Deerfield Imaging, Inc. has had eight other recalls on record since February 20, 2018. Other recent recalls of similar products include IMRIS ORT300 Operating Room Table Recall (August 6, 2026), I.T.S. Hand Locking Plates System (January 23, 2026), and IMRIS ORT200 Operating Room Table Recall (August 6, 2026).

How to tell if you have this one

Check if your MRI system has a serial number from the list: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01. These units were sold with the specific model designations.

  • Brand
    Deerfield Imaging
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Verify your MRI system's serial number against the list: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, New Hampshire, Ohio, Texas.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: Apr 4, 201812. FDA classified it Class II: May 4, 201823. Published in FDA’s Enforcement Report: May 16, 201834. FDA terminated the recall: Jul 22, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1645-2018 (April 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1645-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA