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Recall Observatory FDA recall evidence

Device product

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

Z-0556-2024

November 07, 2023

Class III

Product summary

Firm
APN Health LLC
Event
Event 93419
Status
Ongoing
Classification
Class III
Quantity
1 unit
Official record key
device-enforcement:Z-0556-2024

Official wording

Reason: IFU update

Code information: UDI (01)00869781000308(11)180309(21)2UA7520XNT

Distribution pattern: US Nationwide distribution in the state of WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    IFU update