FDA recall Z-0556-2024
APN Health LLC · Class III · device
Product
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Reason for recall
IFU update
Distribution
US Nationwide distribution in the state of WI.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-11-07
- Report date
- 2023-12-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waukesha, WI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0556-2024