Federal regulators have posted two recalls covering 19 specialized operating room tables after the manufacturer determined that a component failure can leave a table unable to move properly between locked and unlocked states, creating a risk that it could rotate while a patient is on it during a procedure.
The number of tables is small. The setting is not. These are tables used in hybrid neurosurgical suites where the operating table rotates to move a patient between the surgical position and an MRI scanner, often mid-operation while the skull is open. Unintended movement in that setting is a different category of hazard than a device that simply stops working.
No injuries appear in the public recall records, and the tables have not been pulled from hospitals or removed from service. Surgical teams are being told to keep using them under specific daily testing instructions until replacement parts are installed.
Two Recall Records, One Mechanical Fault
The action covers two product lines from IMRIS Imaging Inc of Chaska, Minnesota. The ORT200 record lists six units under recall number Z-3033-2026. The ORT300 record lists 13 units under Z-3034-2026. Both were initiated by the firm on August 6 and posted by regulators on August 26, and both fall under the same recall event.
The manufacturer's stated reason is identical across all records. The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked states, which the company says may pose a risk of injury to the patient if "unintended rotational movement occurs during a procedure." Regulators recorded the determined cause as a nonconforming material or component.
Both are Class II recalls, the middle severity tier, used when a product may cause temporary or medically reversible harm and serious consequences are considered unlikely. Distribution is worldwide, covering the United States plus Canada, China, Japan, and Sweden. Individual serial numbers are listed in each record, which is how a hospital biomedical engineering department confirms whether a specific table in a specific suite is covered. Canadian regulators posted a parallel notice in Canada describing the same corrective action.
Daily Testing Until Parts Arrive
The corrective plan is a field repair rather than a removal. IMRIS says it will replace the linear actuator and rotational lock components with an updated design, with company field service personnel performing the work at each facility.
In the meantime, the urgent notification sent to customers asks surgical teams to test the table daily in all standard positions and inspect for anomalies, including the fit of covers, tabletops, headrest, pendant connection, and rotation. During use, staff are instructed to verify that the table is locked by manually pushing it to confirm it does not rotate, and to contact IMRIS customer service immediately if the floor-latching mechanism is not functioning properly.
That instruction is worth reading carefully, because it places the safety check on the operating room team rather than on the device. A daily manual push test is a reasonable interim measure and acknowledges that the lock cannot currently be trusted to report its own state. In practice, it adds a step to a pre-operative checklist in rooms that already run long setup procedures, and it depends on staff performing it consistently on every shift.
What the Records Do and Do Not Establish
Recall records of this kind are written for manufacturers and hospital engineering departments, and what a device recall involves is often narrower than the word suggests. A correction leaves the product in place under revised instructions until the fix is installed.
What the records do not say is how many failure reports prompted the action, whether any patient was injured, or which hospitals hold the affected units. Regulators have not published that information, and the company has not either. Facilities were notified directly and asked to return a customer acknowledgment form, so the information exists internally even though it is not public.
Both records remain open until corrections are complete. The FDA device recall database will reflect status changes.
Perspective for Patients Facing Brain Surgery
Nobody should postpone neurosurgery over this recall. Nineteen tables represent a very small fraction of the number of operating rooms in the country; the affected facilities have been notified directly, and delaying a scheduled brain or spine operation carries risks that dwarf anything described here.
Patients scheduled for surgery in an intraoperative MRI suite, the kind found at large academic centers, can reasonably ask whether their facility uses IMRIS tables and whether any are covered by the open correction. Hospitals track this through biomedical engineering departments and can answer.
The honest summary is that a manufacturer found a component fault, disclosed it, and put an interim check in place while replacement parts are installed, and that regulators judged the residual risk to be moderate rather than severe.
Key Questions Answered
What was recalled? IMRIS ORT200 and ORT300 operating room tables, six units and 13 units respectively, across two recall records covering the same fault.
What is the defect? Linear actuator and rotational lock components may fail mechanically, preventing the table from moving properly between locked and unlocked states.
What is the risk to patients? The manufacturer says unintended rotational movement during a procedure could injure a patient.
Are the tables being removed from hospitals? No. Facilities may continue using them while following daily testing instructions until replacement parts are installed.
How serious is the classification? Class II, indicating possible temporary or reversible harm, with serious consequences considered unlikely.
Has anyone been injured? No injuries appear in the public recall records, and regulators have not published the number of failure reports behind the action.
Should I delay scheduled surgery? No. Ask your hospital whether it uses affected tables, but do not postpone a needed operation over this recall.
