FDA Medical Device Recalls (openFDA)
APN Health LLC: Navik 3D v2, REF NAVIK3D, 3D Mapping System
- Recall number
- Z-0556-2024
- Recalling firm
- APN Health LLC
- Product
- Navik 3D v2, REF NAVIK3D, 3D Mapping System
- Status
- Open, Classified
- Initiated
- 2023-11-07
- Posted
- 2023-12-14
- Terminated
- not on file
- Reason
- IFU update
- Root cause
- Process control
- Action
- 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.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of WI.
- Lot, serial or model codes
- UDI (01)00869781000308(11)180309(21)2UA7520XNT
- 510(k) numbers
- ["K152160"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3014282601
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28