Recall Z-0556-2024— APN Health LLC
Class III · Ongoing
Class III FDA medical device recall by APN Health LLC, initiated 2023-11-07. It names one FDA 510(k) clearance: K152160. Product: Navik 3D v2, REF NAVIK3D, 3D Mapping System. Reason: IFU update.
- Recalling firm
- APN Health LLC
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2023-11-07
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Reason for recall
IFU update
Data sourced from openFDA. This site is unofficial and independent of the FDA.