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
Enforcement
- Recall Number
- Z-1338-2023
- Event ID
- 91782
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Moberg Research, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 12, 2023
- Initiation Date
- February 20, 2023
- Classification Date
- April 4, 2023
- Address
- 224 S Maple Way, Ambler, PA, 19002-5528, United States
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
Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC
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
Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden.
89 units