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Advanced Bionics, LLC recalls AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to
Recalled May 27, 2020 · FDA recall Z-2032-2020 · Advanced Bionics
Hazard
hearing performance degradation due to body-fluid entering the device. · FDA Class II
Units
8159 units (CI-1601-04 = 3827 units and CI-1601-05 = 4332 units)
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China, Australia, India, South Korea, Thailand, Ecuador, Mexico, El Salvador, Guatemala, Malaysia, Myanmar, Taiwan, Chile, Costa Rica, Colombia, Panama, Japan, Argentina, Peru, Singapore, China, New Zealand, Vietnam, Dominican Republic Refer to uploaded consignee lists in Associated Documents: Exhibit 05_ConsigneeList_Center_17FEB2020 Exhibit 06_ConsigneeList_Professionals_17FEB2020 Exhibit 07_ConsigneeList_Patients_17RFEB2020
Description
hearing performance degradation due to body-fluid entering the device.
Product
AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
Manufacturer(s)
Advanced Bionics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →