Imactis recalls Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Naviga…

Recall date

August 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2972-2020

FDA classification

Class II

Brand / firm

Imactis

Sold / distributed

US Nationwide distribution including in the states of FL & WI.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)