Boston Scientific Corporation: ACCOLADE SR SL MRI (Model L310)

Hazard

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).

Details from the source

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: 50,135 units Lot/code info: GTIN 00802526558948, Serial Numbers: 701140, 701954, 702152, 702176, 702278, 702560, 702997, 702998, 703023, 703075, 703125, 703128, 703138, 703169, 703172, 703201, 703203, 703251, 703253, 703272, 703307, 703324, 703331, 703343, 703395, 703427, 703447, 703451, 703458, 703504, 703508, 703534, 703538, 703546, 703547, 703628, 703656, 703754, 703790, 703839, 704235, 704285, 704300, 704307, 704351, 704493, 704495, 704563, 704590, 704877, 705061, 705070, 705078, 705085, 705105, 705130, 705163, 705169, 705192, 705196, 705225, 705253, 705261, 705270, 705443, 705446, 705523, 705526, 705529, 705541, 705545, 705546, 705573, 705579, 705584, 705587, 705593, 705612, 706491, 707091, 707196, 707376, 707777, 708269, 708354, 709408, 709434, 709521, 709549, 709575, 709578, 709659, 709678, 709687, 709710, 709744, 709750, 709773, 709794, 709813, 709824, 709844, 709862, 709905, 709918, 709930, 709945, 709949, 709950, 709962, 709972, 709986, 710005, 710006, 710014, 710027, 710035, 710036, 710046, 710047, 710061, 710062, 710072, 710075, 710102, 710105, 710139, 710148, 710151, 710174, 710176, 710207, 710276, 710332, 710354, 710413, 710421, 710423, 710446, 710468, 710472, 710474, 710485, 710487, 710492, 710500, 710509, 710511, 710512, 710524, 710527, 710529, 710545, 710549, 710550, 710592, 710594, 710597, 710626, 710644, 710692, 710698, 710711, 710727, 710765, 710873, 710875, 710876, 710879, 710885, 710893, 710899, 710900, 710910, 710912, 710914, 711138, 711139, 711140, 711148, 711163, 711164, 711166,

UPC codes

00802526558948

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.