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

Medical DevicesSource: FDA (device) · Date: 2026-09-02

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
IMRIS Imaging Inc
Product
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
Recall initiated
2026-08-06
Code info
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
Product quantity
13 units
Voluntary mandated
Voluntary: Firm initiated
City
Chaska
State
MN
Country
United States
Event id
99596
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