Medical device recalls Moderate risk

Moberg Research, Inc. recalls Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that coll…

Recall date
February 20, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1338-2023
FDA classification
Class II
Brand / firm
Moberg Research, Inc.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden.

Why it was recalled

Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350

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