Recall Z-2568-2018— Natus Neurology Inc

Name: FDA recall Z-2568-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-01

Class II · Terminated

Class II FDA medical device recall by Natus Neurology Inc, initiated 2018-02-01, terminated 2022-10-21. It names one FDA 510(k) clearance: K021185. Product: Nicolet¿ Ambulatory EEG. Reason: Potential to be able to import an ambulatory exam for a patient for which the exam was not started..

Recalling firm: Natus Neurology Inc
Classification: Class II
Status: Terminated
Initiated: 2018-02-01
Terminated: 2022-10-21
Firm location: Middleton, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K021185 — NERVUS MONITORTaugagreining HF·cleared 2002-07-12

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

Nicolet¿ Ambulatory EEG

Reason for recall

Potential to be able to import an ambulatory exam for a patient for which the exam was not started.

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