FDA Medical Device Recalls (openFDA)
Deerfield Imaging, Inc.: 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.
- Recall number
- Z-1645-2018
- Recalling firm
- Deerfield Imaging, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2018-04-04
- Posted
- not on file
- Terminated
- 2020-07-22
- 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.
- Root cause
- Device Design
- Action
- IMRIS sent Service bulletin T200627-B01 Rev dated March 14, 2018. - through email to all affected customers. The letter identified the affected product, the problem, and the actions required to be taken by the customer. For questions contact IMRIS Customer Support 866-475-0525.
- Quantity
- 10 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
- Lot, serial or model codes
- Serial Numbers: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01
- 510(k) numbers
- K133692
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3010326005
- Firm city
- Minnetonka
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28