Imactis recalls NaviKit stereotaxic accessories for CT systems due to a needle holder defect that may cause inaccurate needle placement, risking organ damage. Affected units include specific lots and reference numbers.
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
Imactis is recalling its NaviKit stereotaxic accessory for CT systems because a defect in the needle holder can cause inaccurate needle placement during procedures, potentially damaging nearby organs or blood vessels. This recall affects specific production lots and reference numbers.
The needle holder has a defect where one jaw fails to grip properly. If not detected before use, this can lead to inaccurate needle placement, potentially causing damage to nearby organs or blood vessels during medical procedures.
Medical professionals using the NaviKit accessory for CT scans are most at risk, particularly those who rely on precise needle guidance during procedures. Patients undergoing such procedures may also be affected if the accessory is used incorrectly.
Check for the reference number I10100 and lots 20060001 or 20060005 on the accessory. The UDI-DI code B681I101002 is also associated with this recall.
Look for the reference number I10100 and lots 20060001 or 20060005 on the accessory.
Yes, the defect can cause inaccurate needle placement, potentially damaging nearby organs or blood vessels during procedures.
Check for the reference number I10100 and lots 20060001 or 20060005 on the accessory. Contact Imactis for further instructions.
The affected units have the reference number I10100 and lots 20060001 or 20060005, with UDI-DI code B681I101002.
We’ve drafted a message you can send Imactis to request your refund or repair — edit it as you like.
Subject: Recall Z-1264-2021 — Imactis Imactis Hello, I own a Imactis that is covered by recall Z-1264-2021 from Imactis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
