Philips North America Llc recalls SENSE Breast Coil

Hazard / Issue

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: REF: 453530083951; UDI-DI: 00884838066588; Serial No. 36987, 36587, 36690, 36898, 37009, 36637, 37129, 37140, 36957, 36549, 36548, 36547, 36893, 36678, 36736, 36743, 36744, 36763, 36770, 36882, 36897, 36938, 36939, 37012, 36585, 36622, 36618, 36639, 36635, 36650, 36648, 36732, 36681, 36676, 36769, 36861, 36885, 36878, 36883, 36890, 36894, 36950, 36941, 36994, 37000, 36998, 36993, 37130, 37159, 37160, 36874, 37032, 37053, 37208, 37127, 37148, 37151, 37143, 36559, 37007, 37141, 36544, 36552, 36580, 36557, 36564, 36630, 36738, 36754, 36762, 36768, 36592, 36603, 36632, 36629, 36673, 36626, 36667, 36660, 36671, 36653, 36691, 36737, 36740, 36749, 36735, 36750, 36747, 36771, 36796, 36803, 36798, 36802, 36794, 36812, 36842, 36741, 36847, 36930, 36865, 36860, 36864, 36867, 36877, 36853, 36884, 36876, 36919, 36880, 36896, 36901, 36891, 36963, 36933, 36899, 36908, 36913, 36907, 36912, 36915, 36983, 36972, 36929, 36931, 36935, 36928, 36927, 36943, 36932, 36942, 36992, 36945, 36940, 36948, 36955, 36949, 37003, 36954, 36953, 36956, 36967, 36966, 36962, 36989, 37004, 37006, 37022, 36974, 37043, 37015, 37020, 37001, 37005, 37014, 37018, 37038, 37072, 37010, 37011, 37026, 37024, 37017, 37019, 37021, 37028, 36988, 37025, 37051, 37055, 37084, 37031, 37029, 37070, 37036, 37042, 37052, 37071, 37056, 37034, 37074, 37092, 37041, 37080, 37079, 37095, 37090, 37118, 37133, 37125, 37085, 37124, 37142, 37122, 37150, 37163, 37139, 37147, 37137, 37176, 37173, 37157, 37155, 37152, 37161, 37179, 37164, 37162, 37191, 37181, 37182, 37188, 37243, 37226, 37190, 37192, 37206, 37195, 37207, 37238, 37214, 37222, 37225, 37234, 37264, 36662, 37280, 36581, 36910, 37040, 37016, 37128, 37138, 37165, 36873, 36996, 36606, 36920, 37169, 37268, 37265, 36553, 36652, 36797, 36905, 37282, 37283, 36947, 37167, 36633, 36624, 37136, 36565, 36636, 36644, 36661, 36654, 36602, 36730, 36758, 36815, 36839, 36862, 36888, 36895, 36926, 36997, 36991, 36985, 37008, 37078, 37126, 37154, 37178, 37174, 37184, 37193, 37186, 37199, 37185, 37189, 37175, 37273, 37242, 37272, 37267, 37224, 37119, 37131, 37123, 37153, 37166, 37200, 37210, 37196, 37223, 37211, 37239, 37266, 36655, 37044, 37039, 36801, 36809, 36537, 36576, 36556, 36568, 36535, 36666, 36674, 37281, 37083, 37076, 37114, 36863, 36811, 37097, 36871, 36575, 36599, 36638, 36600, 36649, 37054, 36566, 36806, 36808, 37096, 36545, 36623, 37121, 36795, 36608, 36611, 36964, 36973, 36669, 36586, 36583, 36904, 36569, 36960, 36921, 36923, 36936, 36951, 37035, 36946, 37177, 37221, 36846, 36625, 36677, 36817, 36870, 36748, 36563, 36539, 36698, 36664, 36686, 36810, 36914, 37183, 36577, 37073, 36656, 36813, 36909, 36906.