Imactis Recalls
3 recalls on record · January 29, 2020 to March 24, 2021 · Medical Devices
Recalls by year
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 24, 2021Medical DevicesFDA
Imactis recalls Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Hazard: 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
September 23, 2020Medical DevicesFDA
Imactis recalls Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navi
Hazard: 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.
January 29, 2020Medical DevicesFDA
Imactis recalls Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482,
Hazard: 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.