There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
Reason for recall: There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC). Distribution: Worldwide distribution. Quantity: 20715 units Lot/code info: UDI/DI 05415067040763, Serial Numbers: 19400015, 19400017, 19400020, 19400021, 19400022, 19400023, 19400025, 19400026, 19400029, 19400030, 19400031, 19400033, 19400035, 19400037, 19400038, 19400039, 19400040, 19400041, 19400042, 19400043, 19400044, 19400045, 19400048, 19400051, 19473833, 19473834, 19473835, 19473836, 19473837, 19473838, 19473839, 19473840, 19473841, 19473842, 19473843, 19473845, 19473850, 19473851, 19473852, 19473853, 19473854, 19473855, 19473857, 19473859, 19473861, 19473862, 19473866, 19473867, 19473870, 19475756, 19475759, 19475762, 19475763, 19475765, 19475767, 19475768, 19475770, 19475771, 19475772, 19475774, 19475776, 19475777, 19475778, 19475779, 19475780, 19475781, 19475782, 19475783, 19475784, 19475785, 19475788, 19475789, 19475791, 19475793, 19475794, 19475796, 19475799, 19475800, 19475802, 19475804, 19475805, 19475807, 19475809, 19475810, 19475811, 19475812, 19475813, 19475815, 19475816, 19475818, 19475823, 19475824, 19475825, 19475826, 19475827, 19475829, 19475830, 19475832, 19475833, 19475834, 19475835, 19493395, 19493397, 19493398, 19493399, 19493401, 19493402, 19493403, 19493404, 19493405, 19493406, 19493407, 19493408, 19493410, 19493411, 19493415, 19493416, 19493417, 19493418, 19493421, 19493422, 19493423, 19493424, 19493425, 19493426, 19493427, 19493428, 19493429, 19493431, 19493432, 19493433, 19493434, 19493435, 19493436, 19493437, 19493438, 19493439, 19493440, 19493442, 19493445, 19493446, 19493447, 19493448, 19493449, 19493450, 19493451, 1
05415067040763
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.