FDA Device recall Z-2972-2020
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (RE…
- FDA Device
- Class II
- ongoing
- Published 2020-09-23
On 2020-09-23 the FDA classified a Class II recall of Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (RE… by Imactis, citing 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 fiduc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2972-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-08-24 |
| Published | 2020-09-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Imactis |
| Distribution | US |
Product
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
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.
Identifiers
| code_info | All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2972-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.