Medical device recalls

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

Recall date
November 7, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0556-2024
FDA classification
Class III
Brand / firm
APN Health LLC
Sold / distributed
US Nationwide distribution in the state of WI.

Why it was recalled

IFU update

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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