Device evidence

device-recall:cfres:163559

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.

Official recall number

Z-1645-2018

Evidence summary

Product code: LNH
Recall status: Terminated
Event initiated: April 04, 2018
Root cause: Device Design
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-1645-2018