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: 722 units Lot/code info: UDI/DI 05415067047663, Serial Numbers: 20196493, 20196495, 20196496, 20196497, 20196498, 20196500, 20196502, 20196503, 20196504, 20196505, 20196506, 20196507, 20196508, 20196509, 20196511, 20196512, 20196513, 20196514, 20196515, 20196516, 20196517, 20207397, 20207398, 20207399, 20207400, 20207401, 20207402, 20207403, 20207405, 20207406, 20207407, 20207408, 20207409, 20207410, 20207411, 20207412, 20207413, 20207414, 20207415, 20207416, 20207417, 20207418, 20207419, 20207420, 20207421, 20207422, 20207423, 20207424, 20207425, 20207427, 20207428, 20207429, 20207430, 20207431, 20207432, 20207433, 20207434, 20207435, 20207436, 20207437, 20207438, 20207441, 20207442, 20207443, 20207444, 20207445, 20207446, 20207447, 20207448, 20207449, 20207450, 20207451, 20207452, 20207454, 20207455, 20207456, 20207457, 20207458, 20207459, 20207460, 20207461, 20207462, 20207463, 20207464, 20207465, 20207466, 20207467, 20207468, 20207469, 20207470, 20207471, 20207472, 20207473, 20207474, 20207477, 20207478, 20207481, 20207482, 20207483, 20207484, 20207485, 20207486, 20207487, 20207488, 20207489, 20207490, 20207491, 20207494, 20207495, 20207496, 20208681, 20208682, 20208683, 20208684, 20208685, 20208686, 20208687, 20208688, 20208689, 20208690, 20208691, 20208692, 20208693, 20208695, 20208696, 20208697, 20208698, 20208699, 20208701, 20208703, 20208704, 20219079, 20219080, 20219081, 20219082, 20219083, 20219084, 20219085, 20219086, 20219087, 20219088, 20219089, 20219090, 20219091, 20219092, 20219093, 2
05415067047663
Official record: FDA (Device enforcement) ↗
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