Device product
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Z-1264-2021
Product summary
- Firm
- Imactis
- Event
- Event 87391
- Status
- Terminated
- Classification
- Class II
- Quantity
- 105 kits
- Official record key
device-enforcement:Z-1264-2021
Official wording
Reason: 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
Code information: Lots #: 20060001, 20060005 UDI-DI: B681I101002
Distribution pattern: NJ, NY, WI
Derived failure modes
-
Unknown
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