Deerfield Imaging, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1645-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 4, 2018

Date Posted: May 16, 2018

Recall Number: Z-1645-2018

Event ID: 79816

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.

Status: Terminated

Product Quantity: 10 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated