Imactis Recall 87391
Description: Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Imactis Recall 87391 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1264-2021 |
| Event ID | 87391 |
| Event Description | Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 |
| Product Type | Devices |
| Distribution | NJ, NY, WI |
| Quantity | 105 kits |
| Recall 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 |
| Device Classification | 20210324 |
| Device Code Info | Lots #: 20060001, 20060005 UDI-DI: B681I101002 |
| Center Classification Date | 20210316 |
| Recall Initiation Date | 20210211 |
| Recalling Firm | Imactis |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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