Navik 3D v2, REF NAVIK3D, 3D Mapping System
FDA device recall Z-0556-2024 · posted 2023-12-14 · Open, Classified
Recall details
- Recalling firm
- APN Health LLC
- Reason for recall
- IFU update
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DQK
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of WI.
- Date initiated
- 2023-11-07
- Date posted
- 2023-12-14
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Navik 3D (K152160) | Apn Health, LLC | 2016-02-23 |