APN Health Navik 3D v2 3D Mapping System Recall: IFU Update Hazard

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Contact the company & request your remedy

Recalling firmAPN Health LLC20935 Swenson Dr Ste 160, N/A · Waukesha, WI 53186-2057

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

APN Health is recalling their Navik 3D v2 3D Mapping System because of a potential issue with the IFU (Instruction for Use) update. This recall is important because the update could lead to problems with the device's operation.

Why it’s dangerous

The recall is due to a potential issue with the IFU update, which could affect the device's operation. However, the specific hazard mechanism is not clearly described in the recall notice.

Who’s affected

Users of the Navik 3D v2 3D Mapping System with the specific UDI code (01)00869781000308(11)180:0309(21)2UA7520XNT are affected. Most at risk are those using the device for medical purposes.

How to tell if you have this one

Check for the UDI code (01)00869781000308(11)180309(21)2UA7520XNT on the device. The product was sold by APN Health LLC.

Brand
APN Health
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device UDI
Look for the UDI code (01)00869781000308(11)180309(21)2UA7520XNT on the device.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to a potential issue with the IFU update, but the specific hazard mechanism is not clearly described in the notice.

How can I tell if my device is affected?

Check for the UDI code (01)00869781000308(11)180309(21)2UA7520XNT on the device.

What should I do if I have this device?

The recall notice does not specify a remedy, so contact APN Health LLC for further instructions.

Take action

Contact APN Health

We’ve drafted a message you can send APN Health to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0556-2024 — APN Health APN Health

Hello,

I own a APN Health that is covered by recall Z-0556-2024 from APN Health.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0556-2024 (November 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0556-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

APN Health LLC recalls Navik 3D v2, REF NAVIK3D, 3D Mapping System

Recall notice