Z-1645-2018Class II

IMRIS IMRI 1.5T AND 3T S System

Name: Z-1645-2018 IMRIS IMRI 1.5T AND 3T S System
Creator: Deerfield Imaging, Inc.
Published: 2018-04-04
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2018-04-04 / Terminated / root cause: design

FDA source

Deerfield Imaging, Inc. began a recall of 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... on 2018-04-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1645-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-04
Posted: 2018-05-04
Terminated: 2020-07-22
Recalling firm: IMRIS Imaging, Inc.
Product: 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 shielded room to facilitate intraoperative and multi room use.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: IMRIS sent Service bulletin T200627-B01 Rev dated March 14, 2018. - through email to all affected customers. The letter identified the affected product, the problem, and the actions required to be taken by the customer. For questions contact IMRIS Customer Support 866-475-0525.
Quantity in commerce: 10 units
Distribution: Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
Product codes and lots: Serial Numbers: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1645-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1645-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code LNH

K133692Class IIImri 1.5T and Imri 3T SImris, Inc. / cleared 2014-02-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)