ORT300 Table recallZ-3034-2026 · IMRIS Imaging Inc · initiated Aug 6, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from IMRIS Imaging Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 not function properly, please contact IMRIS Customer Service immediately. Please confirm receipt of this notice with IMRIS using the Customer Acknowledgement Form below, and please forward this communication to any others inside or outside your organization who may work with the affected ORT200 and ORT300 tables. To minimize the potential risk of injury, IMRIS is taking the following corrective actions: " The existing ORT200 and ORT300 linear actuator and rotational lock mechanism components will be replaced with an updated design. Our customer service organization will contact you to make arrangements for IMRIS field service personnel to perform the correction at your facility. IMRIS has identified that your facility has one or more ORT200 or ORT300 Operating Tables which are subject to this recall notice. Please confirm details on the last page of this letter and return your response to IMRIS. IMRIS Customer Service will contact you to facilitate replacement of the linear actuator and rotational lock mechanism components at your facility. Please contact our customer support team through our service line at 1-866-475-0525 or e-mail: [email protected] if you have any questions or concerns. Please keep this information until the corrective measures have been finalized.
Recall details
- Recall number
- Z-3034-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 6, 2026
- Posted by the FDA
- Aug 26, 2026
- Recalling firm
- IMRIS Imaging Inc
- Quantity
- 13 units
- Product code
- KXJ
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
Product description
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Code information (models, lots, serial numbers)
114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 - UDI-DI: 00857534006462, Serial Numbers: 10002996, 10004515, 10007411, 10007376
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ORT300 TableIMRIS Imaging, Inc. · Table, Operating-Room, Ac-Powered2 recalls21 reports
- ORT300 TableIMRIS Imaging, Inc. · Table, Radiologic2 recalls6 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99596).
- Z-3033-2026 · Open, ClassifiedORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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