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Terminated

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.

FDA Recall Z-1645-2018 · Posted None

Recalling FirmDeerfield Imaging, Inc.
Recall StatusTerminated
Product CodeLNH
Date Initiated2018-04-04
Date Terminated2020-07-22
Product Quantity10 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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