FDA recall Z-1338-2023

Product

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

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden.

Key facts

Status

Ongoing

Initiation date

2023-02-20

Report date

2023-04-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ambler, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1338-2023