Z-2972-2020 Class II Ongoing
FDA device recall Z-2972-2020 was initiated by Imactis on August 24, 2020 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 6 Navigation Systems.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2020
- Initiation Date
- August 24, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 Navigation Systems
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.
Distribution Pattern
US Nationwide distribution including in the states of FL & WI.
Code Information
All Serial Numbers