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.
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Contact the company
📍Recalling firmImactis20 Rue Du Tour De L Eau · St Martin D Heres, France
“Imactis Patient Fiducial Recall: Separation Risk Affects Navigation Accuracy.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64437-imactis-patient-fiducial-recall-separation-risk-affects-navigation-accuracy. Based on FDA recall #Z-2972-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2972-2020%22&limit=1).
The FDA announced on August 24, 2020, that Imactis is recalling its Patient Fiducial (Patient Referential) component due to the risk of the disk separating from the body. This defect could lead to navigation inaccuracies or improper needle trajectory during use.
Used with: Imactis CT-Navigation Workstation (REF J02000/J00180)
Serial Numbers: All Serial Numbers
Quantity: 6 Navigation Systems
The hazard
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.
Context
GovInfoNow's records show Imactis has two other recalls on record since August 1, 2019. On February 11, 2021, Imactis issued a recall for its NaviKit Stereotaxic Accessory due to the risk of inaccurate needle placement. On August 1, 2019, Imactis recalled its Navigation Kit because of microbial contamination risk. Other recent recalls of similar products include GE Medical Systems Imactis CT-Navigation System Recall (February 3, 2026) and Merit Medical Allwell Inflation Device Recall (December 4, 2025).
How to tell if you have this one
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).
Brand
Imactis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Component Status
Verify if the patient fiducial disk has separated from the device and if it's been reassembled.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of FL & WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Wisconsin.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2972-2020 (August 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2972-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.