Z-1264-2021Class II

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

Name: Z-1264-2021 Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Creator: Imactis
Published: 2021-02-11
License: https://open.fda.gov/license/

Imactis, SAS / initiated 2021-02-11 / Terminated / root cause: manufacturing process

FDA source

Imactis began a recall of Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 on 2021-02-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1264-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-11
Posted: 2021-03-16
Terminated: 2023-10-05
Recalling firm: Imactis, SAS
Product: Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 105 kits
Distribution: NJ, NY, WI
Product codes and lots: Lots #: 20060001, 20060005 UDI-DI: B681I101002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1264-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1264-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-16

Product code JAK

K162314Class IIIMACTIS CT-Navigation systemImactis, Sas / cleared 2018-04-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)