Recall Z-0556-2024 ยท DQK Computer, Diagnostic, Programmable
APN Health LLC
Navik 3D v2, REF NAVIK3D, 3D Mapping System
| Date | Dec 14, 2023 (initiated Nov 7, 2023) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152160 | Navik 3D Apn Health, LLC, Feb 23, 2016 |