Z-2568-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- February 1, 2018
- Termination Date
- October 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171 units
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.
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.
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