FDA Medical Device Recalls (openFDA)
Imactis: Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
- Recall number
- Z-1264-2021
- Recalling firm
- Imactis
- Product
- Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
- Status
- Terminated
- Initiated
- 2021-02-11
- Posted
- not on file
- Terminated
- 2023-10-05
- 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
- Root cause
- Process control
- Action
- Imactis notified users by visit on 2/11/221 and issued Urgent Medical Device Recall on 2/25/21 via email to consignees. Letter states reason for recall, health risk and action to take: Customers are requested to quarantine any product from the affected NaviKit" lot numbers and return them to Imactis Affected NaviKit lot numbers will be quarantined and removed from the market. New compliant product will be sent to customers to replace the removed lot numbers. As the defect is visually detectable, product will be inspected internally according to an approved procedure and any defective needle holders will be sorted and replaced with compliant ones. Refurbished NaviKit" product will not be sold to customers. Your IMACTIS representative for questions: Robert Hornak (VP Sales, North America) - 205-542-1486 (Cell) - 205-542-1486 (cell) Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time
- Quantity
- 105 kits
- Distribution
- NJ, NY, WI
- Lot, serial or model codes
- Lots #: 20060001, 20060005 UDI-DI: B681I101002
- 510(k) numbers
- ["K162314"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3015060224
- Firm city
- Heres
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28