Recall Z-0556-2024
APN Health LLC · initiated November 7, 2023
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Codes / lots: UDI (01)00869781000308(11)180309(21)2UA7520XNT
Reason for recall
IFU update
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-0556-2024
- Initiated
- November 7, 2023
- Posted by FDA
- December 14, 2023
- Product code
- DQK – Computer, Diagnostic, Programmable
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of WI.
- Recalling firm
- APN Health LLC, Waukesha, WI