FDA recall, , Moderate risk
IMRIS Operating Room Tables ORT200 and ORT300
The ORT200 operating room table may have a mechanical failure that prevents locking, posing a risk of injury.
Summary by Recall Canary from the FDA notice
What happened
IMRIS Imaging Inc of Chaska, Minnesota recalled the ORT200 and ORT300 operating room tables because the linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state, posing a risk of injury to the patient if unintended rotational movement occurs during a procedure.
The recall began August 6, 2026 and was added to the FDA's Enforcement Report on August 26, 2026. Distribution was worldwide, including the US Nationwide and Canada, China, Japan, and Sweden.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
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
- UDI-DI
- 10003754
- 10006997
- 00857534006349
- 10005189
- 10005190
- 10004463
- 10004997
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
- UDI-DI
- 00857534006356
- 10005695
- 10002998
- 10002997
- 10005456
- 10005612
- 10004372
- 10005613
- 10002841
- 10011119
- 00857534006462
- 10002996
- 10004515
- 10007411
- 10007376
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
- Company
- IMRIS Imaging IncChaska, Minnesota
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99596
- Recall numbers
- Z-3033-2026 to Z-3034-2026
All recalls from IMRIS Imaging Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
