Summary
The FDA issued a Class III for Navik 3D v2, REF NAVIK3D, 3D Mapping System by APN Health LLC. Reason: IFU update.
Details
Source
Device Recall
External ID
Z-0556-2024
Action Date
2023-12-20
Status
Ongoing
Category
device
Product Description
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Lot/Code Info: UDI (01)00869781000308(11)180309(21)2UA7520XNT
Quantity Affected: 1 unit
Reason for Recall
IFU update
Distribution
US Nationwide distribution in the state of WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-07
Company
Waukesha, WI
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 238 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (APN Health LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does APN Health LLC have FDA actions?
This is the only FDA action we have on record for APN Health LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0556-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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