Moberg CNS-350 Neuromonitoring System Recalled for Battery Leakage Risk
Moberg is recalling 89 CNS-350 Neuromonitoring System devices due to battery leakage that can corrode the metal enclosure, potentially causing skin injury. Affected units were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a potential hazard from battery leakage and corrosion that could cause skin injury, but no reported illnesses or injuries have been documented. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Moberg Research, Inc. is recalling 89 units of the Moberg Component Neuromonitoring System (CNS Monitor), Model CNS-350. This is a short-term neurological monitoring system designed to collect, display, and store physiological measurements.
The recall is due to battery leakage that can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact with corrosive materials could cause injury to skin.
Affected devices have UDI number B485CNS3501 and specific serial numbers from A-CNS-22502 through A-CNS-22591. The devices were distributed worldwide, including throughout the United States and in France, Germany, Italy, and Sweden.
Patients or healthcare facilities currently using affected units should stop use and contact the manufacturer or their distributor for replacement or repair instructions.
The recalled product
- 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
- Manufacturer
- Moberg Research, Inc.
- Affected units
- 89
Distribution
Distributed nationwide across the United States.
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