Moberg Component Neuromonitoring System (CNS… recallZ-1338-2023 · Moberg Research, Inc. · initiated Feb 20, 2023
Class II Open, Classified All recalls posted in April 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Moberg Research, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1338-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Feb 20, 2023
- Posted by the FDA
- Apr 4, 2023
- Recalling firm
- Moberg Research, Inc.
- Quantity
- 89 units
- Product code
- OMA
- FDA submissions
- K080217
- Distribution
- Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
UDI Number: B485CNS3501 Serial Numbers: A-CNS-22502 A-CNS-22506 A-CNS-22507 A-CNS-22508 A-CNS-22509 A-CNS-22510 A-CNS-22511 A-CNS-22512 A-CNS-22513 A-CNS-22525 A-CNS-22526 A-CNS-22527 A-CNS-22528 A-CNS-22529 A-CNS-22530 A-CNS-22534 A-CNS-22535 A-CNS-22536 A-CNS-22537 A-CNS-22541 A-CNS-22542 A-CNS-22543 A-CNS-22544 A-CNS-22545 A-CNS-22546 A-CNS-22547 A-CNS-22548 A-CNS-22549 A-CNS-22550 A-CNS-22551 A-CNS-22552 A-CNS-22553 A-CNS-22554 A-CNS-22555 A-CNS-22556 A-CNS-22557 A-CNS-22558 A-CNS-22559 A-CNS-22560 A-CNS-22561 A-CNS-22562 A-CNS-22564 A-CNS-22565 A-CNS-22566 A-CNS-22567 A-CNS-22568 A-CNS-22569 A-CNS-22570 A-CNS-22571 A-CNS-22572 A-CNS-22573 A-CNS-22574 A-CNS-22575 A-CNS-22577 A-CNS-22578 A-CNS-22584 A-CNS-22585 A-CNS-22586 A-CNS-22587 A-CNS-22588 A-CNS-22589 A-CNS-22590 A-CNS-22591
Other devices under the same FDA submission
1 device cleared under K080217 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Component Neuromonitoring System CNS-350Moberg Research Inc · Full-Montage Standard Electroencephalograph2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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