FDAAugust 24, 2020device
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Official recall recorded by the U.S. Food & Drug Administration.
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.
What to do
FDA enforcement status: Ongoing
Brands named
imactis
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAImpactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I101002021-02-11
- 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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