CLASS III ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report
Navik 3D v2 recalled by APN Health
APN Health is recalling Navik 3D v2, distributed nationwide in the US. The recall was initiated on 7 Nov 2023 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0556-2024
- FDA event ID
- 93419
- Recalling firm
- APN Health, Waukesha, WI
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 7 Nov 2023
- FDA classified
- 14 Dec 2023
- Reported
- 20 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Nov 2023 | Recall initiated by company | |
| 14 Dec 2023 | Classified by FDA | +37 days |
| 20 Dec 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
IFU update
Product as listed by the FDA
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Where it was distributed
US Nationwide distribution in the state of WI.
Questions about this recall
Why was it recalled?
IFU update
Which lots are affected?
UDI (01)00869781000308(11)180309(21)2UA7520XNT
Where was it sold?
US Nationwide distribution in the state of WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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