IMRIS Imaging Inc FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and theClass IIAug 6, 2026The linear actuator and rotational lock mechanism components	The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents	Class IIDevices	Aug 6, 2026
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600Class IIAug 6, 2026The linear actuator and rotational lock mechanism components	The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents	Class IIDevices	Aug 6, 2026
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000,Class IIDec 8, 2025Torque screw may crack or separate. If used, an affected scr	Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, co	Class IIDevices	Dec 8, 2025