FDA-Device2020-09-23Class II
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
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.
Sold states
US Nationwide distribution including in the states of FL & WI.
Affected count
6 Navigation Systems
Manufactured in
20 Rue Du Tour De L Eau, N/A, St Martin D Heres, N/A, France
Products
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2972-2020Don't want to check this manually?
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