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ORT200, operating room table, including the ORT200 Covered… recallZ-3033-2026 · IMRIS Imaging Inc · initiated Aug 6, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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-3033-2026
Status
Open, Classified
Initiated by the company
Aug 6, 2026
Posted by the FDA
Aug 26, 2026
Recalling firm
IMRIS Imaging Inc
Quantity
6 units
Product code
FQO
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.

Product description

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

Code information (models, lots, serial numbers)

113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 99596).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page