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Imactis Recall 87391

Description: Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100

Imactis Recall 87391 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1264-2021
Event ID87391
Event DescriptionImpactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Product TypeDevices
DistributionNJ, NY, WI
Quantity105 kits
Recall ReasonDefect 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 Classification20210324
Device Code InfoLots #: 20060001, 20060005 UDI-DI: B681I101002
Center Classification Date20210316
Recall Initiation Date20210211
Recalling FirmImactis
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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