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FDAFDA · Food and drugs·Recall number Z-3034-2026

ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600

Published September 2, 2026 · Recall initiated: August 6, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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 to do

Voluntary: Firm initiated

Recall details

Manufacturer
IMRIS Imaging Inc
Distributor
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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