Medtronic Neuromodulation: 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

Hazard

Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.

Details from the source

Reason for recall: Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility. Distribution: 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, Lebano Quantity: 18,010 units Lot/code info: 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, 0213

UPC codes

00613994544940, 00613994604477, 00613994604484, 00613994604491, 00643169090866, 00643169936584, 00763000111847, 00763000111854, 00763000111861, 00613994544957, 00613994604446, 00613994604453, 00613994604460

Source

Official record: FDA (Device enforcement) ↗

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