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Imactis recalls Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navi
Recalled September 23, 2020 · FDA recall Z-2972-2020 · Imactis
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. · FDA Class II
Units
6 Navigation Systems
Sold at
US Nationwide distribution including in the states of FL & WI.
Description
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.
Product
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Manufacturer(s)
Imactis
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →