FDAClass IINovember 27, 2019

Neocis Guidance System Fiducial Array - Product Usage recall: Nitrosamine Impurity

Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide…

Why was Neocis Guidance System Fiducial Array - Product Usage recalled?

The Fiducial Array may mismatch their measurement files resulting in failed landmark check.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Serial Numbers: FA-0128-02, FA-0129-02, FA0130-02

Product
Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide…
Recalling firm
Neocis Inc.
Quantity
3 units
Distribution
US Nationwide distribution in the states of AR, OK, NY.
Recall date
November 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls