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

Is my product affected?

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

• UPC 00857534006356
• UPC 00857534006462

Check against the official notice below — it lists the full affected range.

What happened

IMRIS Imaging Inc. is recalling 13 ORT300 operating room tables distributed worldwide, including throughout the United States and in Canada, China, Japan, and Sweden. The recalled tables have part numbers 114093-000 or 114093-600, with specific serial numbers listed for each part number. The tables are being recalled because the linear actuator and rotational lock mechanism components may fail mechanically, preventing the system from properly transitioning between locked and unlocked states.

If the lock mechanism fails during a procedure, the operating table could experience unintended rotational movement, which poses a risk of injury to the patient. The recall notice does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden. Quantity: 13 units Lot/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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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 114148-0002026-08-06
• Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.2026-08-06
• Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system may be configured with an Intelligent Cooling Device (ICD) to provide epidermal cooling during laser 2026-08-06
• Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye2026-08-06
• Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);2026-08-07

All FDA (Device enforcement) recalls