Reported Sep 23, 2020 · Ongoing
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the…
Imactis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Imactis · 20 Rue Du Tour De L Eau · St Martin D Heres, N/A · N/A
Is this the product you have?
- Imactis Patient Fiducial (Patient Referential)
- REFIHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
- Lot codes and dates
- All Serial Numbers
- Amount recalled
- 6 Navigation Systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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