Use cautionMedical device recall · FDA · Published February 11, 2021
Imactis NaviKit Stereotaxic Accessory Recall: Risk of Inaccurate Needle Placement
Imactis recalls NaviKit stereotaxic accessories for CT systems due to a needle holder defect that may cause inaccurate needle placement, risking organ damage. Affected units include specific lots and reference numbers.
Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of the needle holder does not provide gripping functionality; if the defect is not detected before use, it can cause poor needle guidance and a lack of precision during navigation causing an inaccurate needle position which could cause damage to organs or vasculature adjacent to the trajectory
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Contact the company
📍Recalling firmImactis20 Rue Du Tour De L Eau · St Martin D Heres, France
“Imactis NaviKit Stereotaxic Accessory Recall: Risk of Inaccurate Needle Placement.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63281-imactis-navikit-stereotaxic-accessory-recall-risk-of-inaccurate-needle-placement. Based on FDA recall #Z-1264-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1264-2021%22&limit=1).
The FDA announced on Feb. 11, 2021, that Imactis is recalling its Impactis NaviKit-stereotaxic accessory for Computed Tomography systems due to a mechanical defect in the needle holder. The agency issued recall number Z-1264-2021.
How to tell if you have it
Brand: Imactis
Product: Impactis NaviKit-stereotaxic accessory for Computed Tomography systems
Reference #: I10100
Lots #: 20060001, 20060005
UDI-DI: B681I101002
The hazard
The defect involves one of the two jaws of the needle holder failing to provide gripping functionality. If undetected, this can cause poor needle guidance and inaccurate positioning, potentially damaging adjacent organs or vasculature.
Context
GovInfoNow's records show Imactis has issued two other recalls since Aug. 1, 2019. On Aug. 24, 2020, the firm recalled a patient fiducial due to separation risks affecting navigation accuracy. On Aug. 1, 2019, Imactis recalled a navigation kit over microbial contamination risks. Other recent recalls of similar products include GE Medical Systems' Feb. 3, 2026 CT-Navigation System recall for potential trajectory mismatch and Medline's Feb. 27, 2026 NAMIC Angiographic Syringes recall for rotation risk.
How to tell if you have this one
Check for the reference number I10100 and lots 20060001 or 20060005 on the accessory. The UDI-DI code B681I101002 is also associated with this recall.
Brand
Imactis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the reference number I10100 and lots 20060001 or 20060005 on the accessory.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “NJ, NY, WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey, New York, Wisconsin.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1264-2021 (February 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1264-2021 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.