Drug recall

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

FDA recall event 93419 · Class III · APN Health LLC

Key facts

Event ID 93419
Recall numbers Z-0556-2024
Recalling firm APN Health LLC
Product type Devices
Products Navik 3D v2, REF NAVIK3D, 3D Mapping System
Classification Class III
Status Ongoing
Voluntary or mandated Firm Initiated
Reason for recall IFU update
Initiation date Nov 7, 2023
Report date Dec 20, 2023
City Waukesha
State WI
Country United States
FEI number 3014282601

At a glance

  • 1–9 Products in this recall
  • 1–9 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date:

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