| Date Initiated by Firm |
February 20, 2023 |
| Date Posted |
April 04, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1338-2023 |
| Recall Event ID |
91782 |
| 510(K)Number |
K080217
|
| Product Classification |
Amplitude-integrated electroencephalograph - Product Code OMA
|
| Product |
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 |
| 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
|
Recalling Firm/
Manufacturer |
Moberg Research, Inc.
224 S Maple Way
Ambler PA 19002-5528
|
| For Additional Information Contact |
SAME
215-283-0860
|
Manufacturer 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
|
FDA Determined
Cause 2 |
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 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. |
| Quantity in Commerce |
89 units |
| Distribution |
Worldwide distribution - US Nationwide and the countries of France, Germany, Italy, Sweden.
|
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = OMA and Original Applicant = MOBERG RESEARCH, INC.
|
