Z-1338-2023 Class II Ongoing
FDA device recall Z-1338-2023 was initiated by Moberg Research, Inc. on February 20, 2023 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 89 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2023
- Initiation Date
- February 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89 units
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
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 Pattern
Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden.
Code Information
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