Navik 3D v2 (APN Health) – IFU Update (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Brand
APN Health LLC
Lot Codes / Batch Numbers
UDI (01)00869781000308(11)180309(21)2UA7520XNT
Products Sold
UDI (01)00869781000308(11)180309(21)2UA7520XNT
APN Health LLC is recalling Navik 3D v2, REF NAVIK3D, 3D Mapping System due to IFU update. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
IFU update
Recommended Action
Per FDA guidance
APN Health, LLC notified its sole consignee on 11/07/2023 via email. The letter notified the consignee of the error in the labeling. The firm corrected the label on site on 10/31/2023.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026