Z-2568-2018Class II

Nicolet Ambulatory EEG

Name: Z-2568-2018 Nicolet Ambulatory EEG
Creator: Natus Neurology Inc
Published: 2018-02-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-02-01 / Terminated / root cause: software

FDA source

Natus Neurology Inc began a recall of Nicolet Ambulatory EEG on 2018-02-01. FDA classified it as Class II and gives the reason as "Potential to be able to import an ambulatory exam for a patient for which the exam was not started". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2568-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-01
Posted: 2018-07-28
Terminated: 2022-10-21
Recalling firm: Medtronic, Inc.
Product: Nicolet Ambulatory EEG
Product code: OLV Standard Polysomnograph With Electroencephalograph
Reason for recall: Potential to be able to import an ambulatory exam for a patient for which the exam was not started.
Root cause tag: software
FDA root cause: Software design
Action: Customers were notified via letter on about 02/01/2018. Instructions to ensure the empty exam is removed appropriately after starting the ambulatory recording included: 1) Only shutdown Recorder via the Recorder UI, either from the File menu or the X button on the top right of the application; 2) If any of the four conditions above occurs and the 2.60 MB exam is not removed, the empty exam can be deleted from NicVue prior to importing the ambulatory exam, doing so will allow the patient ID check to occur normally. Customers were also instructed to provide the recall communication to all applicable users and complete and return the verification form.
Quantity in commerce: 171 units
Distribution: Distributed domestically to AR, AZ, CA, CO, DC, FL, GA, ID, IL, IN, MA, ME, MI, MO, N Y, NC, ND, NJ, NV, NY, PA, TN, TX, VA, WA, WI. Distributed internationally to Australia, Belgium, China, Germany, Hong Kong, Israel, Italy, Jordan, Kuwait, Russia, Slovenia, Tunisia, United Arab Emirates, Vietnam.
Product codes and lots: UDI 00382830043670; Serial Numbers MBR120693, MBR100549, MBR100566, MBR120699, MBR090299, MBR090317, MBR150907, MBR100541, MBR120700, MBR120681, MBR120686, MBR120697, MBR130793, MBR110634, MBR150920, MBR150921, MBR160934, MBR120665, MBR110629, MBR090308, MBR150885, MBR090327, MBR120720, MBR130784, MBR130785, MBR120696, MBR100579, MBR090318, MBR150928, MBR100610, MBR110642, MBR090313, MBR100578, MBR100564, MBR100626, MBR120683, MBR100594, MBR090324, MBR090326, MBR090329, MBR100583, MBR100602, MBR100603, MBR100624, MBR120659, MBR120674, MBR100567, MBR140853, MBR100565, MBR110645, LBR06094, LBR06095, LBR06101, MBR120660, MBR100550, MBR120671, MBR150886, MBR150890, MBR150893, MBR150894, MBR100573, MBR150896, MBR150897, MBR150902, MBR150904, MBR150911, MBR150916, MBR150918, MBR150919, MBR150908, MBR150930, MBR150931, MBR100552, MBR100596, MBR100601, LBR06133, MBR110638, MBR140836, MBR100572, MBR110649, MBR100532, MBR100548, MBR110630, MBR120734, MBR150898, MBR100592, MBR090303, MBR090306, MBR100586, MBR100600, MBR150887, MBR150888, MBR100545, MBR100555, MBR120658, MBR120680, MBR120687, MBR160952, MBR140857, MBR120762, MBR100580, MBR100591, MBR140862, MBR150922, MBR140856, MBR140865, MBR150903, MBR140861, MBR140834, MBR140858, 140859, MBR140863, MBR140864, MBR140866, MBR150884, MBR150917, MBR160936, MBR160941, MBR160962, MBR160969, 80218, LBR120757, LBR120759, LBR120771, MBR110635, MBR110640, MBR110643, MBR110644, MBR110647, MBR120661, MBR120662, MBR120675, MBR120725, MBR120733, MBR140833, MBR140835, MBR140838, MBR100625, MBR150899, MBR110646, MBR150913, MBR090321, MBR090330, MBR100585, MBR100617, MBR110641, MBR120679, MBR120710, MBR120715, MBR120718, MBR120754, MBR120760, MBR120763, MBR130794, MBR140815, MBR150926, LBR06028, LBR06051, MBR100614, MBR100621, MBRL20672, MBR140811, MBR150929, 150923, MBR120653, MBR120713, MBR150925, MBR150891

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2568-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2568-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28

Product code OLV

K021185Class IINervus MonitorTaugagreining HF / cleared 2002-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)