Imactis Patient Fiducial — Class II medical device recall Z-2972-2020
Ongoing recall by Imactis, reported 2020-09-23, distributed nationwide. The firm has received reports concerning the patient fiducial disk separating from the body and users attempti
| Recall number | Z-2972-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Imactis, St Martin D Heres, N/A, France |
| Recall initiated | 2020-08-24 |
| Classified | 2020-09-15 |
| Reported by FDA | 2020-09-23 |
| Distributed | Nationwide (US) |
| Quantity | 6 navigation |
| Model numbers | J02000/J00180 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2972-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.