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Recall Observatory FDA recall evidence

Device product

Nicolet¿ Ambulatory EEG

Z-2568-2018

February 01, 2018

Class II

Product summary

Firm
Natus Neurology Inc
Event
Event 80023
Status
Terminated
Classification
Class II
Quantity
171 units
Official record key
device-enforcement:Z-2568-2018

Official wording

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

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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