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Recall Observatory FDA recall evidence

Device product

SENSE Breast Coil

Z-0545-2025

November 04, 2024

Class II

Product summary

Firm
Philips North America Llc
Event
Event 95645
Status
Ongoing
Classification
Class II
Quantity
5,231 units
Official record key
device-enforcement:Z-0545-2025

Official wording

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

Code information: 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.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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