Chaska, MN, United States
IMRIS Imaging Inc recalls
2 recalls recorded since 2018, most recently on 6 August 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 August 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3033-2026, Z-3034-2026
- 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
- ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Ongoing Class II Medical devices
- Recall started
- 8 December 2025
- Reason
- Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1034-2026
- Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Descripti
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.