High FDA (Devices)·Z-1645-2018·Announced 2018-05-16

Deerfield Imaging Recalls IMRIS Intraoperative MRI Systems Due to Malfunction

Deerfield Imaging is recalling 10 IMRIS intraoperative MRI systems because magnetic fields cause the IFOSS collision detector control panel to malfunction.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (MRI system) where a malfunction of the collision detector control panel poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Deerfield Imaging, Inc. is recalling 10 units of the IMRIS IMRI 1.5T and 3T S System. These intraoperative MRI systems are suspended on an overhead rail system and are designated for use inside RF shielded rooms to facilitate intraoperative and multi-room use.

The recall is being issued because the DC power to the IFOSS collision detector control panel is adversely affected by the magnetic field. The manufacturer's investigation determined that the magnetic field is causing the IFOSS control panel to malfunction.

The affected units were distributed worldwide, including in the United States (Ohio, Florida, New Hampshire, Texas), Sweden, and Canada. The specific serial numbers for the recalled units are 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, and 10093-01.

The recalled product

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.
Manufacturer: Deerfield Imaging, Inc.
Category: Medical Device — MRI System
Hazard: malfunction
collision-detector-failure
Affected units: 10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

Serial Numbers: 10111-00
10073-01
10043-01
10097-01
10006-11
10076-21
10081-01
10089-01
10101-01
10093-01

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Deerfield Imaging, Inc.

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