The FDA announced on April 4, 2018, that Deerfield Imaging, Inc. voluntarily recalled IMRIS IMRI 1.5T AND 3T S System intraoperative MRI devices due to a malfunctioning collision detector control panel. The agency issued recall number Z-1645-2018 for the Class II device.
How to tell if you have it
- Brand: Deerfield Imaging
- Product: IMRIS IMRI 1.5T AND 3T S System
- Serial Numbers: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01
- Quantity: 10 units
The hazard
According to the FDA, the magnetic field adversely affects the DC power to the IFOSS collision detector control panel. This causes the control panel to malfunction.
Context
GovInfoNow's records show Deerfield Imaging, Inc. has had eight other recalls on record since February 20, 2018. Other recent recalls of similar products include IMRIS ORT300 Operating Room Table Recall (August 6, 2026), I.T.S. Hand Locking Plates System (January 23, 2026), and IMRIS ORT200 Operating Room Table Recall (August 6, 2026).