St Martin D Heres, N/A, France
Imactis recalls
3 recalls recorded since 2018, most recently on 11 February 2021. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 February 2021
- Terminated
- 5 October 2023
- 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
- Distribution
- NJ, NY, WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1264-2021
- Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Ongoing Class II Medical devices
- Recall started
- 24 August 2020
- Reason
- The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. The use of a re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory.
- Distribution
- US Nationwide distribution including in the states of FL & WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2972-2020
- Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Ongoing Class II Medical devices
- Recall started
- 1 August 2019
- Reason
- The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level of endotoxin sufficient to produce a pyrogenic response.
- Distribution
- US: WI & IL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0838-2020
- Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diamete
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.