Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Imactis Patient Fiducial (Patient Referential) Recalled by Imactis Due to The firm has received reports concerning the patient...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Imactis directly.
Affected Products
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Quantity: 6 Navigation Systems
Why Was This Recalled?
The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. The use of a re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Imactis
Imactis has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report