Deerfield Imaging recalls IMRIS 1.5T and 3T intraoperative MRI systems due to magnetic field causing IFOSS control panel malfunction. Affected units have specific serial numbers.
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.
Deerfield Imaging is recalling IMRIS 1.5T and 3T intraoperative MRI systems because the magnetic field can cause the IFOSS control panel to malfunction. This could lead to improper operation during surgery if not addressed.
The magnetic field generated by the MRI system can interfere with the IFOSS collision detector control panel. This may cause the panel to malfunction, potentially leading to unsafe surgical conditions if the system is not properly maintained.
Medical facilities using the IMRIS 1.5T or 3T intraoperative MRI systems with the listed serial numbers are affected. Surgeons and surgical teams are most at risk during procedures.
Check if your MRI system has a serial number from the list: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01. These units were sold with the specific model designations.
Verify your MRI system's serial number against the list: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01.
The magnetic field can cause the IFOSS control panel to malfunction, which may lead to unsafe surgical conditions.
Check your serial number against the list provided. If it matches, contact Deerfield Imaging for further instructions.
Yes, the malfunction could lead to unsafe surgical conditions if the control panel fails during procedures.
We’ve drafted a message you can send Deerfield Imaging to request your refund or repair — edit it as you like.
Subject: Recall Z-1645-2018 — Deerfield Imaging Deerfield Imaging Hello, I own a Deerfield Imaging that is covered by recall Z-1645-2018 from Deerfield Imaging. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
