Class 3 Device Recall APN HEALTH

• Date Initiated by Firm: November 07, 2023
• Date Posted: December 14, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0556-2024
• Recall Event ID: 93419
• 510(K)Number: K152160
• Product Classification: Computer, diagnostic, programmable - Product Code DQK
• Product: Navik 3D v2, REF NAVIK3D, 3D Mapping System
• Code Information: UDI (01)00869781000308(11)180309(21)2UA7520XNT
• Recalling Firm/ Manufacturer: APN Health LLC; 20935 Swenson Dr Ste 160; Waukesha WI 53186-2057
• For Additional Information Contact: David Geddam; 703-200-4052
• Manufacturer Reason for Recall: IFU update
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 1 unit
• Distribution: US Nationwide distribution in the state of WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DQK