Z-0556-2024 Class III Ongoing
FDA device recall Z-0556-2024 was initiated by APN Health LLC on November 7, 2023 and is designated Class III. Reason for recall: IFU update The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2023
- Initiation Date
- November 7, 2023
- Termination Date
- N/A
- 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