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

This recall is currently active, issued December 14, 2023. It was issued by Apn Health Llc.

Company

Apn Health Llc

Recall Initiated

November 7, 2023

Posted

December 14, 2023

Recall Number

Z-0556-2024

Quantity

1 unit

Firm Location

Waukesha, WI

Official Source

View on FDA website ↗

Reason for Recall

IFU update

Distribution

US Nationwide distribution in the state of WI.

Lot / Code Info

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

Root Cause

Process control

Action Taken

APN Health, LLC notified its sole consignee on 11/07/2023 via email. The letter notified the consignee of the error in the labeling. The firm corrected the label on site on 10/31/2023.