Nicolet¿ Ambulatory EEG
Check against the official notice below — it lists the full affected range.
Natus Neurology Inc is recalling 171 units of Nicolet Ambulatory EEG devices due to a software issue that could allow users to import an ambulatory exam for a patient even when the exam was not started. The affected devices were distributed domestically across 22 U.S. states and internationally to 14 countries including Australia, China, Germany, Israel, Italy, Russia, and Vietnam. The recalled units have specific serial numbers listed and carry the UDI 00382830043670.
The recall record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential to be able to import an ambulatory exam for a patient for which the exam was not started.
Reason for recall: Potential to be able to import an ambulatory exam for a patient for which the exam was not started. 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. Quantity: 171 units Lot/code info: 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, MB
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.