APN Health LLC is recalling one unit of the Navik 3D v2 Mapping System (REF NAVIK3D) due to a necessary update to the Instructions for Use (IFU). This 3D mapping system is used in medical procedures to visualize heart structures. Consumers and healthcare providers should contact the manufacturer or their healthcare provider for specific guidance regarding this update.
The recall is based on an update to the Instructions for Use, which ensures healthcare providers have the most accurate and safe operating procedures for the 3D mapping system. Incorrect or outdated instructions could lead to improper use of the device during medical procedures.
IFU update
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.