Reported May 16, 2018 · Terminated
IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that…
Deerfield Imaging, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Deerfield Imaging, Inc. · 5101 Shady Oak Rd S · Minnetonka, MN · 55343-4100
Is this the product you have?
- IMRIS IMRI 1.5T
- AND 3T S System Product UsageThe 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
- Lot codes and dates
- Serial Numbers
10111-0010073-0110043-0110097-0110006-1110076-2110081-0110089-0110101-0110093-01
- Serial Numbers
- Amount recalled
- 10 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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