Recall Z-1338-2023 ยท OMA Amplitude-Integrated Electroencephalograph
Moberg Research, Inc.
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
| Date | Apr 4, 2023 (initiated Feb 20, 2023) |
| Status | Open, Classified |
| Reason | Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC |
| 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 |
| Quantity | 89 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080217 | COMPONENT NEUROMONITORING SYSTEM Moberg Research, Inc., Nov 5, 2008 |