Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300
Check against the official notice below — it lists the full affected range.
Medtronic Xomed is recalling 1,447 units of its Integrated Power Console (IPC) systems distributed in Japan due to a software defect in version 2.7.3.0. When used with the company's M5 handpiece in a specific mode, the console produced a difference between the number of rotations that were set and the actual number of rotations delivered. The affected products include three console models: Console 1898001 IPC (Product Number 1898001), Console IPC Refurb (Product Number EC300RF), and Master Console EC300 Legend. The recall involves multiple lot and serial numbers.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.
Reason for recall: As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece. Distribution: International distribution country of Japan. Quantity: 1447 units Lot/code info: a) Product Number 1898001, GTIN 00613994752246, Lot Serial Numbers: 72158, 72162, 72167, 72178, 72176, 72205, 72206, 72208, 72234, 72323, 72315, 72326, 72339, 72340, 72342, 72372, 72404, 72419, 72422, 72471, 72509, 72492, 72788, 72818, 72819, 72815, 72816, 72838, 72843, 72639, 72607, 72630, 72632, 73117, 73114, 73115, 73122, 73204, 73206, 73218, 73554, 73354, 73355, 73358, 73359, 73351, 73384, 73408, 73410, 73416, 73420, 73421, 73427, 73431, 73432, 73433, 73430, 73434, 73508, 73510, 73507, 73509, 73539, 73540, 73560, 73561, 73604, 73830, 73844, 73847, 73848, 73851, 73852, 73853, 73855, 73846, 73859, 73856, 73863, 73864, 73874, 73875, 73877, 73878, 73879, 73992, 73993, 73994, 73995, 74014, 74017, 74016, 74036, 74033, 74046, 74047, 74048, 74050, 74055, 74057, 74061, 74062, 74227, 74229, 74231, 74232, 74310, 74313, 74314, 74315, 74317, 74353, 74354, 74386, 74385, 74394, 74434, 74436, 74512, 74577, 74571, 74587, 74590, 74592, 74594, 74595, 74596, 74646, 74647, 74644, 74674, 74763, 74766, 74770, 74769, 74773, 74854, 74880, 74881, 74899, 74900, 74978, 74979, 74980, 74982, 74988, 74989, 74991, 74992, 75008, 75144, 75166, 75206, 75226, 75272, 75313, 75315, 75317, 75422, 75423, 75424, 75426, 75428, 75430, 75456, 75459, 75460, 75462, 75492, 75493, 75495, 75494, 75526, 75529, 75543, 75708, 75709, 75710, 75711, 75712, 75713, 75714, 75725, 75726, 75727, 75769, 75848, 75849, 76056, 76090, 76129, 76127, 76145, 76169, 76171, 76334, 76335, 76360, 76363, 76365, 76362, 76413, 76414, 76476, 7649
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.