FDA Device recall Z-0556-2024
Navik 3D v2, REF NAVIK3D, 3D Mapping System
- FDA Device
- Class III
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class III recall of Navik 3D v2, REF NAVIK3D, 3D Mapping System by Apn Health, citing IFU update.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0556-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-11-07 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Apn Health |
| Distribution | US |
Product
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Reason
IFU update
Identifiers
| code_info | UDI (01)00869781000308(11)180309(21)2UA7520XNT |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0556-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.