Natus Neurology Inc: Nicolet Ambulatory EEG

Recall number

Z-2568-2018

Recalling firm

Natus Neurology Inc

Product

Nicolet Ambulatory EEG

Status

Terminated

Initiated

2018-02-01

Posted

not on file

Terminated

2022-10-21

Reason

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

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

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.

Lot, serial or model codes

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

510(k) numbers

["K021185"]

PMA numbers

not on file

Product code

OLV

Firm FEI

3010611950

Firm city

Middleton

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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