Use caution Medical device recall · FDA · Published August 6, 2026

IMRIS ORT200 Operating Room Table Recall: Risk of Patient Injury from Mechanical Failure

IMRIS recalls ORT200 operating room tables with potential mechanical failure causing unintended patient movement during procedures. Affected units include specific serial numbers and part numbers. Contact IMRIS for remedy details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3033-2026Medical device IMRIS ›

Use caution until it’s fixed

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.

✎ GovInfoNow plain-language explainer

IMRIS is recalling certain operating room tables that may fail to lock properly, risking patient injury during surgery. This could happen if the table moves unexpectedly while a patient is being treated. Read more at govinfonow.com/recall/697845-imris-ort200-operating-room-table-recall-risk-of-patient-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/697845-imris-ort200-operating-room-table-recall-risk-of-patient-injury · Updated September 14, 2026 · FDA enforcement record: FDA #Z-3033-2026

Cite this page

“IMRIS ORT200 Operating Room Table Recall: Risk of Patient Injury from Mechanical Failure.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697845-imris-ort200-operating-room-table-recall-risk-of-patient-injury. Based on FDA recall #Z-3033-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3033-2026%22&limit=1).

The FDA announced on Aug. 6, 2026, that IMRIS Imaging Inc is recalling ORT200 operating room tables due to a mechanical failure risk in the linear actuator and rotational lock mechanism. The agency issued recall number Z-3033-2026 for the voluntary Class II action affecting six units distributed worldwide.

How to tell if you have it

Brand: IMRIS
Product: ORT200 operating room table, including the ORT200 Covered Table Assembly, Reconditioned
Part Number 113821-600 - Serial Numbers: 10003754, 10006997
Part Number 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997

The hazard

Context

GovInfoNow's records show IMRIS Imaging Inc has one other recall on record since Dec. 8, 2025: the HFD100 Head Fixation Device Recall regarding torque screw issues. Other recent recalls of similar products include Philips Azurion 3 M15 System Recall (Jan. 26, 2026), Philips Azurion 7 B20 System Recall (Jan. 26, 2026), and Philips Azurion 5 M12 System Software Recalls (Jan. 26, 2026).

How to tell if you have this one

Check for the ORT200 model with specific serial numbers: 10003754, 10006997 (Part 113821-600) or 10005189, 10005190, 10004463, 10004997 (Part 114148-000).

Brand
IMRIS
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.

Recall number	Product, codes & lots	Quantity
Z-3033-2026	ORT200, 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; 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997	6 units
Z-3034-2026	ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600; 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	13 units

Based on the official FDA remedy

What to do — step by step

Check Table Status
Verify if your ORT200 table has the specific serial numbers listed in the recall notice.
Contact IMRIS
Reach out to IMRIS Imaging Inc for guidance on next steps and potential remedies.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 27 days after the firm started it.

Aug 6, 2026Firm started the recall
Aug 26, 2026FDA classified it Class II
Sep 2, 2026Published in FDA’s Enforcement Report
Sep 8, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/697845-imris-ort200-operating-room-table-recall-risk-of-patient-injury">IMRIS ORT200 Operating Room Table Recall: Risk of Patient Injury from Mechanical Failure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-3033-2026 (August 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3033-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.