Navik 3D v2, REF NAVIK3D, 3D Mapping System recallZ-0556-2024 · APN Health LLC · initiated Nov 7, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from APN Health LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
IFU update
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0556-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 7, 2023
- Posted by the FDA
- Dec 14, 2023
- Recalling firm
- APN Health LLC
- Quantity
- 1 unit
- Product code
- DQK
- FDA submissions
- K152160
- Distribution
- US Nationwide distribution in the state of WI.
Product description
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Code information (models, lots, serial numbers)
UDI (01)00869781000308(11)180309(21)2UA7520XNT
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Navik 3D Navik 3D v2.0Apn Health · Computer, Diagnostic, Programmable1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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