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Recall Observatory FDA recall evidence

Device 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.

Z-1645-2018

April 04, 2018

Class II

Product summary

Firm
Deerfield Imaging, Inc.
Event
Event 79816
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-1645-2018

Official wording

Reason: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.