Recall Z-1338-2023— Moberg Research, Inc.

Name: FDA recall Z-1338-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-20

Class II · Ongoing

Class II FDA medical device recall by Moberg Research, Inc., initiated 2023-02-20. It names one FDA 510(k) clearance: K080217. 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. 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.

Recalling firm: Moberg Research, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-20
Firm location: Ambler, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K080217 — COMPONENT NEUROMONITORING SYSTEMMoberg Research, Inc.·cleared 2008-11-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.