Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that colle
Summary
The FDA issued a Class II for Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term n by Moberg Research, Inc.. Reason: Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury .
Details
Source
Device Recall
External ID
Z-1338-2023
Action Date
2023-04-12
Status
Ongoing
Category
device
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
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
Quantity Affected: 89 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-20
Company
Ambler, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 130 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Moberg Research, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Moberg Research, Inc. have FDA actions?
This is the only FDA action we have on record for Moberg Research, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1338-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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