The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled the Model 2868 Application loaded on the 3120 ZOOM LATITUDE programmer, which is used to communicate with Boston Scientific implantable pulse generators. The recall affects 17,172 units that were distributed worldwide. There is potential for unanticipated software anomalies to occur when this programmer communicates with certain Boston Scientific transvenous defibrillators.
The affected devices can be identified by the UPN 00802526434723 and specific serial numbers listed in the recall notice. The source document does not specify what remedy an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Reason for recall: There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators. Distribution: Worldwide Distribution Quantity: 17,172 units in total Lot/code info: UPN: 00802526434723, Serial Numbers: 051026, 051075, 051091, 051121, 051146, 051156, 051171, 051182, 051207, 051232, 051236, 051239, 051270, 051320, 051335, 051358, 051367, 051370, 051374, 051413, 051418, 051425, 051432, 051435, 051456, 051459, 051473, 051478, 051486, 051487, 051495, 051501, 051511, 051533, 051535, 051549, 051552, 051558, 051561, 051580, 051584, 051592, 051593, 051612, 051623, 051626, 051632, 051640, 051655, 051696, 051727, 051745, 051763, 051769, 051770, 051784, 051808, 051818, 051846, 051850, 051863, 051906, 051924, 051931, 051989, 051997, 052018, 052022, 052030, 052034, 052088, 052131, 052145, 052202, 052320, 052460, 054970, 054981, 054993, 054996, 055007, 055016, 055020, 055023, 055037, 055041, 055048, 055059, 055065, 055066, 055069, 055070, 055079, 055086, 055089, 055098, 055113, 055117, 055122, 055132, 055142, 055148, 055154, 055157, 055172, 055174, 055191, 055193, 055205, 055211, 055213, 055214, 055219, 055227, 055246, 055248, 055253, 055256, 055270, 055277, 055306, 055330, 055336, 055343, 055344, 055345, 055350, 055360, 055362, 055376, 055386, 055387, 055388, 055416, 055424, 055449, 055454, 055479, 055501, 055507, 055527, 055537, 055541, 055546, 055568, 055570, 055578, 055580, 055586, 055591, 055625, 055641, 055650, 055658, 055662, 055665, 055666, 055675, 055676, 055677, 055689, 055693, 055697, 055703, 055709, 055721, 055726, 055733, 055735, 055743, 055747, 055750, 055755, 055758, 055789, 055791, 055793, 055799, 055800, 055812, 055813, 055818, 055856,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.