CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Imris Imri 1.5T And 3T S System recalled by Deerfield Imaging
Deerfield Imaging is recalling Imris Imri 1.5T And 3T S System, distributed nationwide in the US. The recall was initiated on 4 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1645-2018
- FDA event ID
- 79816
- Recalling firm
- Deerfield Imaging, Minnetonka, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Apr 2018
- FDA classified
- 4 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 4 Apr 2018 | Recall initiated by company | |
| 4 May 2018 | Classified by FDA | +30 days |
| 16 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
Questions about this recall
Why was it 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.
Which lots are affected?
Serial Numbers: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01
Where was it sold?
Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Deerfield Imaging
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|---|---|---|---|---|---|
| Device | CLASS II | Trumpf Mount Clamp Assembly (table adapter component) recalled | Deerfield Imaging | Other | Nationwide |
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| Device | CLASS II | Core Services Hub V8, a set of backend services including recalled | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Haylard Univ Imaging Biopsy Trucustom kits recalled by Avid Medical | Avid Medical | Sterility | 4 states |