Impactis NaviKit-stereotaxic accessory for Computed recall
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Why was Impactis NaviKit-stereotaxic accessory for Computed 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots #: 20060001, 20060005 UDI-DI: B681I101002
- Product
- Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
- Recalling firm
- Imactis
- Quantity
- 105 kits
- Distribution
- NJ, NY, WI
- Recall date
- March 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)