Recall Z-2972-2020— Imactis
Class II · Ongoing
Class II FDA medical device recall by Imactis, initiated 2020-08-24. It names one FDA 510(k) clearance: K162314. Product: Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180). 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..
- Recalling firm
- Imactis
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-08-24
- Firm location
- St Martin D Heres, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.