Z-0556-2024Class III

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

Name: Z-0556-2024 Navik 3D v2, REF NAVIK3D, 3D Mapping System
Creator: APN Health LLC
Published: 2023-11-07
License: https://open.fda.gov/license/

Apn Health, LLC / initiated 2023-11-07 / Open, Classified / root cause: manufacturing process

FDA source

APN Health LLC began a recall of Navik 3D v2, REF NAVIK3D, 3D Mapping System on 2023-11-07. FDA classified it as Class III and gives the reason as "IFU update". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0556-2024
Classification: Class III
Status: Open, Classified
Initiated: 2023-11-07
Posted: 2023-12-14
Recalling firm: Apn Health, LLC
Product: Navik 3D v2, REF NAVIK3D, 3D Mapping System
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: IFU update
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: UDI (01)00869781000308(11)180309(21)2UA7520XNT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0556-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0556-2024	Class III	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-14

Product code DQK

K152160Class IINavik 3DApn Health, LLC / cleared 2016-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)