Z-1338-2023Class II

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

Name: Z-1338-2023 Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system...
Creator: Moberg Research, Inc.
Published: 2023-02-20
License: https://open.fda.gov/license/

Moberg Research, Inc. / initiated 2023-02-20 / Open, Classified

FDA source

Moberg Research, Inc. began a recall of Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple... on 2023-02-20. FDA classified it as Class II and gives the reason as "Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1338-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-20
Posted: 2023-04-04
Recalling firm: Moberg Research, Inc.
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
Product code: OMA Amplitude-Integrated Electroencephalograph
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
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 89 units
Distribution: Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1338-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1338-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-04

Product code OMA

K080217Class IIComponent Neuromonitoring SystemMoberg Research, Inc. / cleared 2008-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)