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IMRIS recalls
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for IMRIS and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-01-14FDA-DeviceClass IIStop 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.
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