IMRIS recalls
3 federal recalls on file. We read every CPSC, FDA, USDA and NHTSA notice for IMRIS and put it in plain English.
Recent recalls
IMRIS operating suites recalled with Baxter TruSystem surgical tablesIMRIS is recalling five operating suite models that include ORT400 tables, because the operating suites contain Baxter TruSystem surgical tables that Baxter is recalling. The five products are the iMRX System, Neuro III-SV, iMRI 3T S, InVision 3T Operating Suite and InVision 1.5T Operating Suite, with 22 units affected in total. The notice reports no injuries and does not specify a remedy; it was distributed in the US and China.
ModerateFDANov 12, 20265 products
- IMRIS ORT200 and ORT300 operating tables recalled for locking risk
IMRIS is recalling 2 operating room table models, the ORT200 and ORT300, with 19 affected units. A mechanical failure in the linear actuator and rotational lock can stop the table from switching between locked and unlocked, which could allow unintended rotation during a procedure. No injuries have been reported.
SeriousFDASep 2, 20262 products
- Stop using affected IMRIS HFD100 devices
The torque screw in certain IMRIS HFD100 Head Fixation Devices may crack or separate during use. This could cause the device to fail to hold a patient's head securely during surgery, potentially affecting surgical accuracy and requiring emergency use of backup fixation methods.
SeriousFDAJan 14, 2026