Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Reported: September 23, 2020 Initiated: August 24, 2020 #Z-2972-2020
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.
Details
- Recalling Firm
- Imactis
- Units Affected
- 6 Navigation Systems
- Distribution
- US Nationwide distribution including in the states of FL & WI.
- Location
- St Martin D Heres, N/A
Frequently Asked Questions
What product was recalled? ▼
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180). Recalled by Imactis. Units affected: 6 Navigation Systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2020. Severity: Moderate. Recall number: Z-2972-2020.
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