Z-0556-2024 Class III
FDA device recall Z-0556-2024 was initiated by APN Health LLC on Nov 7, 2023 and is designated Class III. Reason for recall: IFU update Affected quantity: 1 unit.
Recall details
- Product Type
- Devices
- Report Date
- Dec 20, 2023
- Initiation Date
- Nov 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product description
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Reason for recall
IFU update
Distribution pattern
US Nationwide distribution in the state of WI.
Code information
UDI (01)00869781000308(11)180309(21)2UA7520XNT
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0556-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026