A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1

Recall details

Manufacturer

Medtronic Neuromodulation

Distributor

Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Canary Islands, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, Viet Nam.

Lot

Versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). 1. Model Number 64001, GTIN (Serial Numbers): 00613994544940 (N733965, N733969, N753252, N775354, N776291, N778120, N782773); 00613994604477 (0212774778, 0212775744, 0212775759, 0212776600, 0212793056, 0212804629, 0212805718, 0212864338, 0212874932, 0212890560, 0212890575, 0212895213, 0212895214, 0212895215, 0212907133, 0212932970, 0212932973, 0212932974, 0212935897, 0213003936, 0213011214, 0213037083, 0213103554, 0213103836, 0213103947, 0213119751, 0213126252, 0213126253, 0213126254, 0213126257, 0213126258, 0213126259, 0213145327, 0213238728, 0213238729, 0213238730, 0213238731, 0213238732, 0213238733, 0213296336, 0213296338, 0213296636, 0213336983, 0213336984, 0213379975, 0213391332, 0213403188, 0213410729, 0213447187, 0213453300, 0213453301, 0213462755, 0213462757, 0213494778, 0213503190, 0213512318, 0213512796, 0213513281, 0213526864, 0213526865, 0213526866, 0213526867, 0213526868, 0213526869, 0213526870, 0213526871, 0213526872, 0213557150, 0213557151, 0213557152, 0213566074, 0213575790, 0213589299, 0213612423, 0213612424, 0213612425, 0213627695, 0213632311, 0213632313, 0213643879, 0213643880, 0213649861, 0213649862, 0213649863, 0213649865, 0213649867, 0213649868, 0213649869, 0213649870, 0213649872, 0213649873, 0213649874, 0213649875, 0213649876, 0213662356, 0213917402, 0213938623, 0213938624, 0213938625, 0213938626, 0213938638, 0214153105, 0214153106, 0214220352, 0214220353, 0214220354, 0214220355, 0214220357, 0214221962, 0214221963, 0214447748, 0214447749, 0214490072, 0214494047, 0214494053, 0214494054, 0214494055, 0214494056, 0214503001, 0214528433, 0214537122, 0214537123, 0214539376, 0214574012, 0214574462, 0214617689, 0214617821, 0214694530, 0214694659, 0214734073, 0214734078, 0214734591, 0214735109, 0214735110, 0214827966, 0214892177, 0214892179, 0214899543, 0215002059, 0215039974, 0215068207, 0215069053, 0215157787, 0215170344, 0215172048, 0215189210, 0215191813, 0215204255, 0215546041, 0215546042, 0215546043, 0215546044, 0215624458, 0215631140, 0215732518, 0215744823, 0215774217, 0215781838, 0215781840, 0215782467, 0215782468, 0215782722, 0215796016, 0215796020, 0215803678, 0215803679, 0215857526, 0215857530, 0215898037, 0215899117, 0215899118, 0216018172, 0216171381, 0216171382, 0216207616, 0216346119, 0216377773, 0216403976, 0216419016, 0216499028, 0216499029, 0216499030, 0216499031, 0216658942, 0216658943, 0216664566, 0216759284, 0216774939, 0216774940, 0216810077, 0216810078, 0216810079, 0216810080, 0216810081, 0216919717, 0216919718, 0216970034, 0216977281, 0217000199, 0217046494, 0217057275, 0217067679, 0217067680, 0217067722, 0217068512, 0217068513, 0217068514, 0217170714, 0217170715, 0217170716, 0217170717, 0217170718, 0217170719, 0217170720, 0217179190, 0217179191, 0217179192, 0217179193, 0217179195, 0217179196, 0217179197, 0217179198, 0217179199, 0217306044, 0217306045, 0217309986, 0217309987, 0217309988, 0217309989, 0217309990, 0217309991, 0217309992, 0217333857, 0217333858, 0217333859, 0217333860, 0217333861, 0217333862, 0217333863, 0217440249, 0217596169, 0217596170, 0217619906, 0217664192, 0217671944, 0217671945, 0217750243, 0217927627, 0218001371, 0218173517, 0218318172, 0218318175, 0218318178); 00613994604484 (0213209850, 0213288462, 0213293456, 0213293457, 0213293458, 0213352261, 0213419249, 0213419340, 0213473603, 0213495294, 0213495295, 0213495296, 0213495297, 0213495298, 0213495299, 0213495340, 0213495341, 0213495342, 0213559327, 0213716708, 0213766926, 0213890732, 0213890733, 0214094542, 0214311406, 0214311407, 0214311408, 0214311414, 0214311415, 0214311416, 0214311419, 0214311474, 0214311475, 0214311476, 0214311477, 0214319850, 0214319853, 0214319967, 0214319968, 0214331598, 0214331599, 0216688332, 0216812514, 0217671913, 0217826925, 0217829246, 0217829247, 0217829248); 00613994604491 (0213925833, 0214282967, 0214282968, 02143016

Risk classification

Class II

Area (FDA)

device

Country

United States