Imactis recalls patient fiducial components used with CT navigation workstations due to separation risks causing navigation inaccuracies. All units are affected.
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.
Imactis is recalling patient fiducial components that can separate from the device, potentially causing navigation errors during procedures. This affects users who rely on accurate imaging guidance.
The patient fiducial disk may separate from the device during use. If reassembled incorrectly, it can cause navigation errors like improper needle placement during procedures.
Users of Imactis CT navigation workstations with the patient fiducial component are affected. Medical professionals performing procedures requiring precise imaging guidance are most at risk.
The recalled component is labeled 'Imactis Patient Fid: (Patient Referential), REF: IHR-YY-XXX'. It's used with ImactisCT-Navigation Workstations (serial numbers J02000/J00180).
Verify if the patient fiducial disk has separated from the device and if it's been reassembled.
The recall specifically affects the patient fiducial component used with ImactisCT-Navigation Workstations (serial numbers J02000/J00180).
If the disk separates, users may attempt to reassemble it, which could cause navigation inaccuracies like improper needle placement.
Look for the label 'Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX' on the component used with ImactisCT-Navigation Workstations.
We’ve drafted a message you can send Imactis to request your refund or repair — edit it as you like.
Subject: Recall Z-2972-2020 — Imactis Imactis Hello, I own a Imactis that is covered by recall Z-2972-2020 from Imactis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
