Home / Recalls / Imactis / Z-2972-2020

Z-2972-2020 Class II Ongoing

Recalled by Imactis — St Martin D Heres, N/A

Recall Details

Product Type: Devices
Report Date: September 23, 2020
Initiation Date: August 24, 2020
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6 Navigation Systems

Product Description

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

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.

Distribution Pattern

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

Code Information

All Serial Numbers