Medical Device Instructions Update Recall for Navik 3D Mapping System
APN Health LLC is recalling the Navik 3D v2 3D Mapping System to update the product instructions for use. The firm initiated this voluntary recall.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall—the lowest-risk classification—for a documentation issue (instructions for use update). No illnesses or injuries have been reported. Per the severity rubric, documentation issues without reported harm are scored as Low (1).
Plain-English summary
APN Health LLC is voluntarily recalling the Navik 3D v2 3D Mapping System (UDI: 00869781000308). The affected unit was distributed nationwide in Wisconsin.
The reason for the recall is to provide an update to the product's instructions for use (IFU). The firm initiated this voluntary recall on November 7, 2023, and the recall was reported to the FDA on December 20, 2023. This is a Class III recall, the FDA's lowest-risk classification for medical devices.
The recalled product
- Product
- Navik 3D v2, REF NAVIK3D, 3D Mapping System
- Manufacturer
- APN Health LLC
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI (01)00869781000308(11)180309(21)2UA7520XNT
Distribution
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