Recall Z-3034-2026 ยท KXJ Table, Radiologic
IMRIS Imaging Inc
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
| Date | Aug 26, 2026 (initiated Aug 6, 2026) |
| Status | Open, Classified |
| Reason | The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter dated 8/6/26 was sent to customers. IMRIS recommends the following preventative actions until the corrective actions have been implemented on your table: " Per the OR Table Operator Manuals, the table should be tested daily in all standard positions and inspected for anomalies including the fit of the covers, tabletops, headrest, pendant connection and rotation. " During usage, verify the table position is locked by manually pushing the table to ensure it does not exhibit rotational movement. " If the floor latching mechanism is observed to |
| Quantity | 13 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.