Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Reason for recall: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). Distribution: Worldwide Quantity: 28,911 units Lot/code info: GTIN 00802526559402, Serial numbers: 100187, 100217, 100222, 100236, 100251, 100253, 100260, 100262, 100274, 100275, 100277, 100289, 100317, 100328, 100330, 100350, 100359, 100361, 100363, 100364, 100369, 100372, 100373, 100376, 100379, 100381, 100386, 100391, 100392, 100394, 100397, 100399, 100400, 100401, 100402, 100404, 100410, 100411, 100414, 100417, 100420, 100433, 100435, 100437, 100444, 100445, 100447, 100449, 100450, 100452, 100453, 100456, 100458, 100459, 100463, 100466, 100471, 100473, 100474, 100475, 100476, 100481, 100482, 100483, 100484, 100485, 100486, 100491, 100497, 100500, 100501, 100502, 100503, 100506, 100507, 100511, 100513, 100514, 100519, 100520, 100522, 100523, 100527, 100533, 100535, 100536, 100537, 100539, 100541, 100544, 100545, 100547, 100550, 100551, 100553, 100556, 100557, 100560, 100562, 100563, 100564, 100565, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100577, 100580, 100581, 100583, 100586, 100589, 100590, 100592, 100593, 100595, 100596, 100601, 100605, 100607, 100615, 100616, 100618, 100619, 100620, 100621, 100624, 100626, 100627, 100633, 100635, 100637, 100639, 100641, 100646, 100648, 100650, 100652, 100655, 100656, 100657, 100662, 100666, 100669, 100670, 100672, 100673, 100678, 100682, 100683, 100685, 100686, 100687, 100688, 100697, 100700, 100702, 100707, 100708, 100709, 100715, 100717, 100718, 100719, 100721, 100724, 100725, 100726, 100727, 100730, 100735, 100736, 100740, 100748, 100749, 100750, 100757, 100759, 100761, 100765,
00802526559402
Official record: FDA (Device enforcement) ↗
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