FDAFebruary 11, 2021device
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
imactis
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAImactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)2020-08-24
- FDAImactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,2019-08-01
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