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[Recalled] Navik 3D v2, REF NAVIK3D, 3D Mapping System — IFU update | FDA 2023-11-07

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductNavik 3D v2, REF NAVIK3D, 3D Mapping System
Brand / manufacturerAPN Health LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0556-2024
Country of noticeUnited States
Risk levelClass III
Hazard typerecall
Notice date07 November 2023
EAN / barcode00869781000308

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: IFU update

This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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