FDAClass IIIDecember 20, 2023

Navik 3D v2 recall

Navik 3D v2, REF NAVIK3D, 3D Mapping System

Why was Navik 3D v2 recalled?

IFU update

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?

UDI (01)00869781000308(11)180309(21)2UA7520XNT

Product
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Recalling firm
APN Health LLC
Quantity
1 unit
Distribution
US Nationwide distribution in the state of WI.
Recall date
December 20, 2023
Classification
Class III
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls