FDAFDA · Food and drugs·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)
Published September 23, 2020 · Recall initiated: August 24, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Imactis
- Distributor
- US Nationwide distribution including in the states of FL & WI.
- Lot
- All Serial Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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