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 is recalling the Model 2868 Application loaded on the 3120 ZOOM LATITUDE programmer due to potential unanticipated software anomalies that could occur when the device communicates with certain Boston Scientific transvenous defibrillators. The recall affects approximately 17,172 units that were distributed worldwide, with specific serial numbers identified for the affected devices.
The source document does not specify a remedy or recommended action for affected consumers.
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.