Device product
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Z-2972-2020
Product summary
- Firm
- Imactis
- Event
- Event 85258
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 Navigation Systems
- Official record key
device-enforcement:Z-2972-2020
Official wording
Reason: 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.
Code information: All Serial Numbers
Distribution pattern: US Nationwide distribution including in the states of FL & WI.
Derived failure modes
-
Unknown
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.