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Open, Classified

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

FDA Recall Z-0556-2024 · Posted 2023-12-14

Recalling FirmAPN Health LLC
Recall StatusOpen, Classified
Product CodeDQK
Date Initiated2023-11-07
Product Quantity1 unit

Reason for Recall

IFU update

Firm Action

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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152160Navik 3DApn Health, LLC · 2016-02-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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