Reported Mar 24, 2021 · Terminated
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
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?
- Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
- Lot codes and dates
Lots #: 2006000120060005
- UDI-DIB681I101002
- Amount recalled
- 105 kits
Where it was sold
Why it was recalled
Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of the needle holder does not provide gripping functionality; if the defect is not detected before use, it can cause poor needle guidance and a lack of precision during navigation causing an inaccurate needle position which could cause damage to organs or vasculature adjacent to the trajectory
This product could cause temporary or reversible health problems — stop using it.
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