Imactis Patient Fiducial recall
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF…
Why was Imactis Patient Fiducial 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Serial Numbers
- Product
- Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF…
- Recalling firm
- Imactis
- Quantity
- 6 Navigation Systems
- Distribution
- US Nationwide distribution including in the states of FL & WI.
- Recall date
- September 23, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)