medical Class II Updated 2020-09-23

Imactis recalls Imactis Patient Fiducial (Patient Referential), REF: IHR-YY

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Serial Numbers
View official government recall

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