FDA · Class II · September 2, 2026

IMRIS Imaging recall: ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned… and 1 more product

IMRIS Imaging Inc is recalling ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned… and 1 more product – 6 units; 13 units. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on August 6, 2026. Distributed nationwide.

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

An FDA laboratory that tests medical devices
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
ProductORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned… and 1 more product
BrandIMRIS Imaging
CompanyIMRIS Imaging Inc
TypeMedical devices
ClassificationClass II
Recall dateAugust 6, 2026
Published by FDASeptember 2, 2026
Quantity6 units; 13 units
Recall ID99596
As listed by FDA

Recalled products (2)

  1. 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
    FDA recall number
    Z-3033-2026
    Codes, lots and dates
    113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997
    Quantity
    6 units
    Classification
    Class II
  2. ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
    FDA recall number
    Z-3034-2026
    Codes, lots and dates
    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
    Quantity
    13 units
    Classification
    Class II
Exactly as the agency lists them

Identifiers and details

FDA event ID
99596
Initiated
Voluntary: Firm initiated
Status
Ongoing
Firm location
Chaska, MN, United States

Why it was recalled

The reason the FDA lists: “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.”

Where it was sold

Nationwide. Distribution as the FDA records it: “Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99596, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Latest

Other medical device recalls

DateRecallProblemAgency
Oct 7, 2026Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 unitsPotential cracks in the hose, which could lead to leakage or the hose falling off.
Most serious
FDA
Class I
Oct 7, 2026Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 totala fire hazard
Most serious
FDA
Class I
Oct 7, 2026Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepiecesDue to incorrect inside packaging label for eyepiece.
Serious
FDA
Class II
Oct 7, 2026Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 unitsPotential for irregular oxygen readings due to a manufacturing issue affecting certain oxy…
Serious
FDA
Class II
Oct 7, 2026Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS)The potential for falsely elevated results.
Serious
FDA
Class II
Oct 7, 2026Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof…
Serious
FDA
Class II
FAQ

About this recall

Is IMRIS Imaging ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned… recalled?

Yes. IMRIS Imaging Inc recalled it on August 6, 2026; FDA published it September 2, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it 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.

What should I do if I have it?

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

Cookies

We measure traffic so we know which stories you care about. You can change your choice at any time.