Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that colle

FDA device recall Z-1338-2023 · posted 2023-04-04 · Open, Classified

Recall details

Recalling firm

Moberg Research, Inc.

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

Action taken

Natus issued Letters Urgent Medical Device Recall Letter Component Neuromonitoring System (Moberg CNS Monitor Model CNS-350) via first class beginning Feb 20, 2023. Letter states reason for recall, health risk and action to take: Ensure that the CNS is either shut down or plugged into a power outlet. Perform the next step while using proper personal protective equipment (PPE), including gloves. On the top of the CNS-350 device, open each of the three (3) battery ports and remove any backup battery. 2) Inspect the battery and the battery port for any white, brown, or green/blue buildup, or for any corrosion of the metal contact locations. a. Dispose of the battery at your local electronic e-waste facility. Note: The CNS-350 device may continue to be used (while plugged into a power outlet) with the backup battery removed. b. If battery leakage or corrosion is suspected, cease use of the CNS-350 device. New replacement battery will be shipped to you. The Moberg Technical Service department will be in contact with you in relation to the provision of the replacement product. For new battery replacement, installation instructions will be provided with the battery.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OMA

Quantity affected

89 units

Distribution

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

Date initiated

2023-02-20

Date posted

2023-04-04

Location

Ambler, PA

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