IMRIS Imaging recalls

2 official recalls and safety alerts involving IMRIS Imaging since 2026-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with IMRIS Imaging or the relevant agency.

  1. 2026-09-02
  2. US
    Drugs & medicalClass II

    IMRIS Imaging Inc recalls ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz…

    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…

    FDA · DeviceIMRIS Imaging IncWorldwide distribution - US Nationwide and the countries of Canada, China,…Official notice →
  3. 2026-01-14
  4. US
    Drugs & medicalClass II

    IMRIS Imaging Inc recalls Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000,…

    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…

    FDA · DeviceIMRIS Imaging IncWorldwide distribution - US Nationwide and the countries of Canada, Sweden,…Official notice →