FDA Recall
Open, Classified
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Recall: Z-0556-2024
·
Initiated November 7, 2023
Recall
- Recall Number
- Z-0556-2024
- Event Number
- 93419
- Firm
- APN Health LLC
- FEI Number
- 3014282601
- Product Code
- DQK
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 7, 2023
- Posted
- December 14, 2023
- Address
- 20935 Swenson Dr, Ste 160, Waukesha, WI, 53186-2057
Description
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Reason
IFU update
Action
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.
Distribution
US Nationwide distribution in the state of WI.
Quantity
1 unit