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FDAApril 4, 2018device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

deerfield imagingdeerfield

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear