RegWardenFDA facility compliance records
Company

IMRIS Imaging, Inc.

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2025: 1 recalls; 2026: 1 recalls201720182019202020212022202320241202512026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-08-06
    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 procedur…
  • Class IIOngoing2025-12-08
    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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “IMRIS Imaging, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10050332-imris-imaging-inc/

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