FDA Device recall Z-1264-2021
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
- FDA Device
- Class II
- terminated
- Published 2021-03-24
On 2021-03-24 the FDA classified a Class II recall of Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 by Imactis, citing 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 defe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1264-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-11 |
| Published | 2021-03-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Imactis |
| Distribution | NJ, NY, WI |
Product
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
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
Identifiers
| code_info | Lots #: 20060001, 20060005 UDI-DI: B681I101002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1264-2021%22
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