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
- Company
- Moberg Research, Inc.
- Recall Initiated
- February 20, 2023
- Posted
- April 4, 2023
- Recall Number
- Z-1338-2023
- Quantity
- 89 units
- Firm Location
- Ambler, PA
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.
Lot / Code Info
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
Root Cause
Under Investigation by firm
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.