Imactis: Medical Device Recall in 2020 - (Recall #: Z-2972-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 24, 2020

Date Posted: September 23, 2020

Recall Number: Z-2972-2020

Event ID: 85258

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 6 Navigation Systems

Code Information:

All Serial Numbers

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated