NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81…
Official notice from a government agency or its published feed.
Reason: Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Worldwide distribution - US Nationwide and the countries of Japan and South Korea.
Hazard: Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
View the FDA enforcement report ↗ ← All reports